Ridon may be available in the countries listed below.
Ingredient matches for Ridon
Domperidone
Domperidone is reported as an ingredient of Ridon in the following countries:
- Bangladesh
International Drug Name Search
Friday, September 30, 2016
Izometazina
Izometazina may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ingredient matches for Izometazina
Sulfadimidine
Sulfadimidine is reported as an ingredient of Izometazina in the following countries:
- Italy
International Drug Name Search
mirtazapine
Generic Name: mirtazapine (mir TAZ a peen)
Brand Names: Remeron, Remeron SolTab
What is mirtazapine?
Mirtazapine is an antidepressant. Mirtazapine affects chemicals in the brain that may become unbalanced and cause depression.
Mirtazapine is used to treat major depressive disorder.
Mirtazapine may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about mirtazapine?
You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. You should not take this medication if you are allergic to mirtazapine or if you are also taking tryptophan (sometimes called L-tryptophan). Do not use mirtazapine if you have used an MAO inhibitor within the past 14 days. Serious, life-threatening side effects can occur if you take mirtazapine before the MAO inhibitor has cleared from your body.
Before taking mirtazapine, tell your doctor if you have bipolar disorder, liver or kidney disease, seizures, heart disease, a history of heart attack or stroke, or a history of drug abuse or suicidal thoughts.
Video: Treatment for Depression
Treatments for depression are getting better everyday and there are things you can start doing right away.
It may take up to several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 4 weeks of treatment. Drinking alcohol can increase certain side effects of mirtazapine. Mirtazapine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
What should I discuss with my healthcare provider before taking mirtazapine?
You should not take this medication if you are allergic to mirtazapine or if you are also taking tryptophan (sometimes called L-tryptophan). Do not use mirtazapine if you have taken an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use mirtazapine before the MAO inhibitor has cleared from your body.
To make sure you can safely take mirtazapine, tell your doctor if you have any of these other conditions:
- liver or kidney disease;
bipolar disorder (manic depression);
seizures or epilepsy;
low blood pressure or dizzy spells;
high cholesterol or triglycerides;
heart disease, including angina (chest pain);
a history of heart attack or stroke; or
a history of drug abuse or suicidal thoughts.
You may have thoughts about suicide while taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.
Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.
FDA pregnancy category C. It is not known whether mirtazapine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether mirtazapine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
The orally disintegrating tablet may contain phenylalanine. Talk to your doctor before using this form of mirtazapine if you have phenylketonuria (PKU).
How should I take mirtazapine?
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Take the regular tablet form of mirtazapine with water.
To take mirtazapine orally disintegrating tablets (Remeron SolTab):
Keep the tablet in its blister pack until you are ready to take the medicine. Open the package and peel back the foil from the tablet blister. Do not push a tablet through the foil or you may break the tablet.
Using dry hands, remove the tablet and place it in your mouth. It will begin to dissolve right away.
Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.
Swallow several times as the tablet dissolves. No water is needed.
Mirtazapine is usually taken once a day at bedtime. Follow your doctor's instructions.
It may take up to several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 4 weeks of treatment. Do not stop using mirtazapine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using mirtazapine. Store at room temperature, away from moisture and heat.
See also: Mirtazapine dosage (in more detail)
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include confusion, memory problems, drowsiness, and fast heart rate.
What should I avoid while taking mirtazapine?
Drinking alcohol can increase certain side effects of mirtazapine. Mirtazapine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Mirtazapine side effects
Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have a serious side effect such as:
agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;
fever, chills, body aches, flu symptoms;
white patches or sores inside your mouth or on your lips; or
headache, trouble concentrating, memory problems, weakness, feeling unsteady, or confusion.
Less serious side effects include:
drowsiness, dizziness;
increased appetite; or
weight gain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Mirtazapine Dosing Information
Usual Adult Dose for Depression:
Initial dose: 15 mg orally once a day at bedtime.
Maintenance dose: 15 to 45 mg per day.
What other drugs will affect mirtazapine?
Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures or anxiety can add to sleepiness caused by mirtazapine. Tell your doctor if you regularly use any of these medicines
Many drugs can interact with mirtazapine. Below is just a partial list. Tell your doctor if you are using:
cimetidine (Tagamet);
conivaptan (Vaprisol);
imatinib (Gleevec);
isoniazid (for treating tuberculosis);
lithium (Eskalith, LithoBid);
St. John's wort;
tramadol (Ultram, Ultracet);
a blood thinner such as warfarin (Coumadin, Jantoven);
an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), rifampin (Rifadin, Rifater, Rifamate), or telithromycin (Ketek);
an antidepressant such as amitriptyline (Elavil, Vanatrip), citalopram (Celexa), doxepin (Sinequan), desipramine (Norpramin), desvenlafaxine (Pristiq), fluoxetine (Prozac, Sarafem, Symbyax), imipramine (Janimine, Tofranil), nefazodone, nortriptyline (Pamelor), paroxetine (Paxil), sertraline (Zoloft), venlafaxine (Effexor), and others;
antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), or miconazole (Oravig);
heart or blood pressure medication such as nicardipine (Cardene) or quinidine (Quin-G);
HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir);
migraine headache medicine such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), or zolmitriptan (Zomig);
seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol) or phenytoin (Dilantin);
This list is not complete and other drugs may interact with mirtazapine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
More mirtazapine resources
- Mirtazapine Side Effects (in more detail)
- Mirtazapine Dosage
- Mirtazapine Use in Pregnancy & Breastfeeding
- Drug Images
- Mirtazapine Drug Interactions
- Mirtazapine Support Group
- 127 Reviews for Mirtazapine - Add your own review/rating
- mirtazapine Advanced Consumer (Micromedex) - Includes Dosage Information
- Mirtazapine MedFacts Consumer Leaflet (Wolters Kluwer)
- Mirtazapine Professional Patient Advice (Wolters Kluwer)
- Mirtazapine Monograph (AHFS DI)
- Remeron Prescribing Information (FDA)
- Remeron Consumer Overview
- Remeron SolTab Orally Disintegrating Tablets MedFacts Consumer Leaflet (Wolters Kluwer)
Compare mirtazapine with other medications
- Anxiety
- Depression
- Hot Flashes
- Insomnia
- Post Traumatic Stress Disorder
Where can I get more information?
- Your pharmacist can provide more information about mirtazapine.
See also: mirtazapine side effects (in more detail)
Betarretin
Betarretin may be available in the countries listed below.
Ingredient matches for Betarretin
Tretinoin
Tretinoin is reported as an ingredient of Betarretin in the following countries:
- Peru
- Venezuela
International Drug Name Search
modafinil
moe-DAF-i-nil
Commonly used brand name(s)
In the U.S.
- Provigil
Available Dosage Forms:
- Tablet
Therapeutic Class: CNS Stimulant
Chemical Class: Amphetamine Related
Uses For modafinil
Modafinil is used to help people who have narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS), or shift work sleep disorder (SWSD) to stay awake during the day. Modafinil does not cure these conditions and will only work as long as you continue to take it.
modafinil is available only with your doctor's prescription.
Before Using modafinil
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For modafinil, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to modafinil or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of modafinil in children younger than 17 years of age. Safety and efficacy have not been established.
Geriatric
Although appropriate studies on the relationship of age to the effects of modafinil have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of modafinil in the elderly. However, elderly patients may have a slower removal of modafinil from the body, which may require an adjustment in the dose for patients receiving modafinil.
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
Breast Feeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking modafinil, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using modafinil with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Citalopram
- Tolvaptan
Using modafinil with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Clomipramine
- Cyclosporine
- Desogestrel
- Dienogest
- Drospirenone
- Estradiol Cypionate
- Estradiol Valerate
- Ethinyl Estradiol
- Ethynodiol Diacetate
- Etonogestrel
- Levonorgestrel
- Medroxyprogesterone Acetate
- Mestranol
- Norelgestromin
- Norethindrone
- Norgestimate
- Norgestrel
- Triazolam
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of modafinil. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol abuse, history of or
- Drug abuse or dependence, history of—Dependence may be more likely to develop.
- Angina (severe chest pain), unstable or
- Heart attack, recent or
- Heart disease—Use with caution. It is not known how modafinil will affect these conditions.
- Depression, history of or
- Hypertension (high blood pressure) or
- Mania, history of or
- Psychosis (mental illness), history of—Use with caution. May make these conditions worse.
- Left ventricular hypertrophy (heart disease), history of or
- Mitral valve prolapse (heart disease) after receiving CNS stimulants—Use is not recommended in patients with these conditions.
- Liver disease, severe—Use with caution. You may require a dose adjustment. Talk with your doctor if you have concerns about this.
Proper Use of modafinil
Take modafinil only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming.
modafinil comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
modafinil does not take the place of getting enough sleep. It should not be used for occasional sleepiness that has not been diagnosed as narcolepsy, sleep apnea, or shift work sleep problems. Ask your doctor for advice about good sleep habits.
If you have sleep apnea and use a continuous positive airway pressure (CPAP) machine at night, continue using this machine with modafinil.
Take modafinil at the same time each day. Do not change the time of day you take modafinil without talking first with your doctor.
You may take modafinil with or without food.
Dosing
The dose of modafinil will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of modafinil. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For narcolepsy or obstructive sleep apnea/hypopnea syndrome:
- Adults and teenagers 17 years of age and older—200 milligrams (mg) once a day, in the morning. Your doctor may increase your dose as needed.
- Teenagers and children younger than 17 years of age—Use and dose must be determined by your doctor.
- For shift work sleep disorder:
- Adults and teenagers 17 years of age and older—200 milligrams (mg) one hour before you begin working.
- Teenagers and children younger than 17 years of age—Use and dose must be determined by your doctor.
- For narcolepsy or obstructive sleep apnea/hypopnea syndrome:
Missed Dose
If you miss a dose of modafinil, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose of modafinil and you remember it before 12:00 noon the same day, take the missed dose as soon as possible.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using modafinil
Your doctor should check your progress at regular visits to make sure that modafinil is working properly. Your blood pressure may need to be checked more often while taking modafinil.
It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients taking modafinil.
Serious skin reactions can occur with modafinil. Stop using modafinil and check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using modafinil.
modafinil may cause you to have a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop taking modafinil and call your doctor right away if you have a skin rash; itching; hives; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using modafinil.
modafinil may cause serious allergic reactions affecting multiple body organs (e.g., heart, liver, or blood cells). Stop using modafinil and check with your doctor right away if you have the following symptoms: chest pain or discomfort, fever and chills, dark urine, headache, rash, stomach pain, unusual tiredness, unusual bleeding or bruising, or yellow eyes or skin.
If you think modafinil is not working properly after you have taken it for a few weeks, do not increase the dose. Instead, check with your doctor.
If you are using a medicine for birth control (such as birth control pills, implants, shots, patches, vaginal rings, or an IUD), it may not work properly while you are taking modafinil. To keep from getting pregnant, use another form of birth control while you are using modafinil and for one month after your last dose. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.
Modafinil may cause some people to feel dizzy, drowsy, have trouble thinking or controlling movements, or trouble seeing clearly. Make sure you know how you react to modafinil before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.
Stop using modafinil and check with your doctor right away if you have the following symptoms while taking the medicine: aggressive behavior, anxiety, depression, hallucinations, mania, thoughts of suicide, or other mental problems.
If you have been taking modafinil for a long time or in large doses and you think you may have become mentally or physically dependent on it, check with your doctor. Some signs of dependence on modafinil are:
- a strong desire or need to continue taking the medicine.
- a need to increase the dose to receive the effects of the medicine.
- withdrawal side effects when you stop taking the medicine.
While you are taking modafinil, be careful to limit the amount of alcohol that you drink.
If you have been taking modafinil in large doses or for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
modafinil Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
- Black, tarry stools
- blurred vision or other vision changes
- chest pain
- chills or fever
- clumsiness or unsteadiness
- confusion
- dizziness or fainting
- increased thirst and urination
- mental depression
- problems with memory
- rapidly changing moods
- shortness of breath
- sore throat
- trembling or shaking
- trouble in urinating
- uncontrolled movements of the face, mouth, or tongue
- unusual bleeding or bruising
- unusual tiredness or weakness
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Agitation or excitement
- fast or pounding heartbeat
- increased blood pressure
- trouble with sleeping
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Anxiety
- headache
- nausea
- nervousness
- Back pain
- belching
- decrease in appetite
- diarrhea
- difficulty having a bowel movement
- dryness of the mouth
- dryness of the skin
- feeling of constant movement of self or surroundings
- flushing or redness of the skin
- heartburn
- indigestion
- muscle stiffness
- sores, ulcers, or white spots on the lips or in the mouth
- sour stomach
- stomach discomfort upset or pain
- stuffy or runny nose
- swelling
- tingling, burning, or prickling sensations in the skin
- vomiting
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: modafinil side effects (in more detail)
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.
More modafinil resources
- Modafinil Side Effects (in more detail)
- Modafinil Dosage
- Modafinil Use in Pregnancy & Breastfeeding
- Modafinil Drug Interactions
- Modafinil Support Group
- 108 Reviews for Modafinil - Add your own review/rating
- Modafinil Professional Patient Advice (Wolters Kluwer)
- Modafinil Monograph (AHFS DI)
- Modafinil MedFacts Consumer Leaflet (Wolters Kluwer)
- Provigil Prescribing Information (FDA)
- Provigil Consumer Overview
Compare modafinil with other medications
- ADHD
- Chronic Fatigue Syndrome
- Depression
- Fatigue
- Hypersomnia
- Narcolepsy
- Obstructive Sleep Apnea/Hypopnea Syndrome
- Shift Work Sleep Disorder
Entron
Entron may be available in the countries listed below.
Ingredient matches for Entron
Ondansetron
Ondansetron hydrochloride (a derivative of Ondansetron) is reported as an ingredient of Entron in the following countries:
- Indonesia
International Drug Name Search
Thursday, September 29, 2016
Testosterone Enanthate
Testosterone Enanthate INJECTION USP
FOR INTRAMUSCULAR USE ONLY C-III
Rx only
Testosterone Enanthate Description
Testosterone Enanthate Injection is a clear, colorless to pale yellow sterile oleaginous solution of Testosterone Enanthate for intramuscular use. Testosterone Enanthate (C26H40O3) M.W. 400.60, is a white or creamy white, crystalline powder. It is odorless or has a faint odor characteristic of heptanoic acid.
It is insoluble in water, very soluble in ether and soluble in vegetable oils. Its structural formula is:
C26H40O3 M.W. 400.60 (CAS-315-37-7)
17β-((1-oxoheptyl)oxy)androst-4-en-3-one
Each mL contains: Testosterone Enanthate 200 mg, Chlorobutanol (Chloral derivative) 0.5% in Sesame Oil q.s.
Androgens are derivatives of cyclopentano-perhydrophenanthrene. Endogenous androgens are C-19 steroids with a side chain at C-17, and with two angular methyl groups. Testosterone is the primary endogenous androgen.
In their active form, all drugs in the class have a 17-beta-hydroxy group. Esterification of the 17-beta-hydroxy group produces compounds (Testosterone Enanthate and testosterone propionate) which have a longer duration of action and are hydrolyzed in vivo to free testosterone.
Androgens are steroids that develop and maintain primary and secondary male sex characteristics.
Testosterone Enanthate - Clinical Pharmacology
Endogenous androgens are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis, and scrotum; the development of male hair distribution, such as beard, pubic, chest and axillary hair; laryngeal enlargement, vocal chord thickening, alterations in body musculature, and fat distribution. Drugs in this class also cause retention of nitrogen, sodium, potassium, phosphorous, and decreased urinary excretion of calcium. Androgens have been reported to increase protein anabolism and decrease protein catabolism. Nitrogen balance is improved only when there is sufficient intake of calories and protein.
Androgens are responsible for the growth spurt of adolescence and for the eventual termination of linear growth which is brought about by fusion of the epiphyseal growth centers. In children, exogenous androgens accelerate linear growth rates, but may cause a disproportionate advancement in bone maturation. Use over long periods may result in fusion of the epiphyseal growth center and termination of growth process.
Androgens have been reported to stimulate the production of red blood cells by enhancing the production of erythropoietic stimulating factor.
During exogenous administration of androgens, endogenous testosterone release is inhibited through feedback inhibition of pituitary luteinizing hormone (LH). At large doses of exogenous androgens, spermatogenesis may also be suppressed through feedback inhibition of pituitary follicle stimulating hormone (FSH).
There is a lack of substantial evidence that androgens are effective in fractures, surgery, convalescence, and functional uterine bleeding.
Pharmacokinetics
Testosterone esters are less polar than free testosterone. Testosterone esters in oil injected intramuscularly are absorbed slowly from the lipid phase; thus, testosterone cypionate and enanthate can be given at intervals of two to four weeks. Suspensions of testosterone or its esters in aqueous media may cause local irritation and the rate of absorption is not always uniform.
Testosterone in plasma is 98 percent bound to a specific testosterone-estradiol binding globulin, and about 2 percent is free. Generally, the amount of this sex-hormone binding globulin in the plasma will determine the distribution of testosterone between free and bound forms, and the free testosterone concentration will determine its half-life.
About 90 percent of a dose of testosterone is excreted in the urine as glucuronic and sulfuric acid conjugates of testosterone and its metabolites; about 6 percent of a dose is excreted in the feces, mostly in the unconjugated form. Inactivation of testosterone occurs primarily in the liver. Testosterone is metabolized to various 17-keto steroids through two different pathways. There are considerable variations of the half-life of testosterone as reported in the literature, ranging from 10 to 100 minutes.
In many tissues, the activity of testosterone appears to depend on reduction of dihydrotestosterone, which binds to cytosol receptor proteins. The steroid-receptor complex is transported to the nucleus where it initiates transcription events and cellular changes related to androgen action.
Indications and Usage for Testosterone Enanthate
1. Males: Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy.
Hypogonadotropic hypogonadism (congenital or acquired) -idiopathic gonadotropin or LHRH deficiency, or pituitaryhypothalamic injury from tumors, trauma, or radiation. (Appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary, however, and are actually of primary importance.)
If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty.Androgens may be used to stimulate puberty in carefully selected males with clearly delayed puberty. These patients usually have a familial pattern of delayed puberty that is not secondary to a pathological disorder; puberty is expected to occur spontaneously at a relatively late date. Brief treatment with conservative doses may occasionally be justified in these patients if they do not respond to psychological support. The potential adverse effect on bone maturation should be discussed with the patient and parents prior to androgen administration. An x-ray of the hand and wrist to determine bone age should be obtained every 6 months to assess the effect of treatment on the epiphyseal centers (See WARNINGS).
2. Females: Androgens may be used secondarily in women with advancing inoperable metastatic (skeletal) mammary cancer who are 1 to 5 years postmenopausal. Primary goals of therapy in these women include ablation of the ovaries. Other methods of counter-acting estrogen activity are adrenalectomy, hypophysectomy, and/or antiestrogen therapy. This treatment has also been used in premenopausal women with breast cancer who have benefited from oophorectomy and are considered to have a hormone-responsive tumor. Judgement concerning androgen therapy should be made by an oncologist with expertise in this field.
Contraindications
Androgens are contraindicated in men with carcinomas of the breast or with known or suspected carcinomas of the prostate, and in women who are or may become pregnant. When administered to pregnant women, androgens cause virilization of the external genitalia of the female fetus. This virilization includes clitoromegaly, abnormal vaginal development, and fusion of genital folds to form a scrotal-like structure. The degree of masculinization is related to the amount of drug given and the age of the fetus, and is most likely to occur in the female fetus when the drugs are given in the first trimester. If the patient becomes pregnant while taking these drugs, she should be apprised of the potential hazard to the fetus.
Warnings
In patients with breast cancer, androgen therapy may cause hypercalcemia by stimulating osteolysis. In patients with cancer, hypercalcemia may indicate progression of bony metastasis. If hypercalcemia occurs, the drug should be discontinued and appropriate measures instituted.
Prolonged use of high doses of androgens has been associated with the development of peliosis hepatis and hepatic neoplasms including hepatocellular carcinoma. (See PRECAUTIONS–Carcinogenesis). Peliosis hepatis can be a life-threatening or fatal complication.
Cholestatic hepatitis and jaundice occur with 17-alpha-alkylandrogens at a relatively low dose. If cholestatic hepatitis with jaundice appears or if liver function tests become abnormal, the androgen should be discontinued and the etiology should be determined. Drug-induced jaundice is reversible when the medication is discontinued.
Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hypertrophy and prostatic carcinoma.
Edema with or without congestive heart failure may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required. If the administration of Testosterone Enanthate is restarted, a lower dose should be used.
Gynecomastia frequently develops and occasionally persists in patients being treated for hypogonadism.
Androgen therapy should be used cautiously in healthy males with delayed puberty. The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every 6 months. In children, androgen treatment may accelerate bone maturation without producing compensatory gain in linear growth. This adverse effect may result in compromised adult stature. The younger the child, the greater the risk of compromising final mature height.
This drug has not been shown to be safe and effective for the enhancement of athletic performance. Because of the potential risk of serious adverse health effects, this drug should not be used for such purpose.
Precautions
General
Women should be observed for signs of virilization (deepening of the voice, hirsutism, acne, clitoromegaly and menstrual irregularities). Discontinuation of drug therapy at the time of evidence of mild virilism is necessary to prevent irreversible virilization. Such virilization is usual following androgen use at high doses and is not prevented by concomitant use of estrogens. A decision may be made by the patient and the physician that some virilization will be tolerated during treatment for breast carcinoma.
Because androgens may alter serum cholesterol concentration, caution should be used when administering these drugs to patients with a history of myocardial infarction or coronary artery disease. Serial determinations of serum cholesterol should be made and therapy adjusted accordingly. A causal relationship between myocardial infarction and hypercholesterolemia has not been established.
Information for the Patient
The physician should instruct patients to report any of the following side effects of androgens:
Adult or Adolescent Males:
Too frequent or persistent erections of the penis.
Women:
Hoarseness, acne, changes in menstrual periods, or more hair on the face.
All Patients:
Any nausea, vomiting, changes in skin color or ankle swelling.
Any male adolescent patient receiving androgens for delayed puberty should have bone development checked every six months.
Laboratory Tests
Women with disseminated breast carcinoma should have frequent determination of urine and serum calcium levels during the course of androgen therapy (See WARNINGS).
Because of the hepatotoxicity associated with the use of 17-alpha-alkylated androgens, liver function tests should be obtained periodically.
Periodic (every 6 months) x-ray examinations of bone age should be made during treatment of prepubertal males to determine the rate of bone maturation and the effect of androgen on the epiphyseal centers.
Hemoglobin and hematocrit should be checked periodically for polycythemia in patients who are receiving high doses of androgens.
Drug Interactions
1. Anticoagulants:
C-17 substituted derivatives of testosterone, such as methandrostenolone, have been reported to decrease the anticoagulant requirements of patients receiving oral anticoagulants. Patients receiving oral anticoagulant therapy require close monitoring, especially when androgens are started or stopped.
2. Oxyphenbutazone:
Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone.
3. Insulin:
In diabetic patients, the metabolic effects of androgens may decrease blood glucose and insulin requirements.
4. ACTH and corticosteroids:
Enhanced tendency toward edema. Use caution when giving these drugs together, especially in patients with hepatic or cardiac disease.
Drug/Laboratory Test Interferences
Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
Carcinogenesis
Animal Data:
Testosterone has been tested by subcutaneous injection and implantation in mice and rats. The implant induced cervical-uterine tumors in mice, which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats.
Human Data:
There are rare reports of hepatocellular carcinoma in patients receiving long-term therapy with androgens in high doses. Withdrawal of the drugs did not lead to regression of the tumors in all cases.
Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hypertrophy and prostatic carcinoma.
Pregnancy
Teratogenic Effects
Pregnancy Category X (See CONTRAINDICATIONS).
Nursing Mothers
It is not known whether androgens are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from androgens, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Androgen therapy should be used very cautiously in children and only by specialists who are aware of the adverse effects on bone maturation. Skeletal maturation must be monitored every six months by an x-ray of hand and wrist (See INDICATIONS AND USAGE and WARNINGS).
Adverse Reactions
Endocrine and Urogenital:
Female:
The most common side effects of androgen therapy are amenorrhea and other menstrual irregularities, inhibition of gonadotropin secretion, and virilization, including deepening of the voice and clitoral enlargement. The latter usually is not reversible after androgens are discontinued. When administered to a pregnant woman, androgens cause virilization of external genitalia of the female fetus.
Male:
Gynecomastia, and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages (See CLINICAL PHARMACOLOGY).
Skin and appendages:
Hirsutism, male pattern of baldness, and acne.
Fluid and Electrolyte Disturbances:
Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates.
Gastrointestinal:
Nausea, cholestatic jaundice, alterations in liver function tests, rarely hepatocellular neoplasms and peliosis hepatis (See WARNINGS).
Hematologic:
Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia.
Nervous System:
Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.
Metabolic:
Increased serum cholesterol.
Miscellaneous:
Inflammation and pain at the site of intramuscular injection and, rarely, anaphylactoid reactions.
Drug Abuse and Dependence
Testosterone Enanthate Injection is classified as a Schedule III controlled substance under the Anabolic Steroids Control Act of 1990.
Overdosage
There have been no reports of acute overdosage with the androgens.
Testosterone Enanthate Dosage and Administration
Dosage and duration of therapy with Testosterone Enanthate Injection will depend on age, sex, diagnosis, patient’s response to treatment, and appearance of adverse effects. When properly given, injections of Testosterone Enanthate are well tolerated. Care should be taken to inject the preparation deeply into the gluteal muscle following the usual precautions for intramuscular administration. In general, total doses above 400 mg per month are not required because of the prolonged action of the preparation. Injections more frequently than every two weeks are rarely indicated.
Male Hypogonadism:
As replacement therapy, i.e., for eunuchism, the suggested dosage is 50 to 400 mg every 2 to 4 weeks.
In Males With Delayed Puberty:
Various dosage regiments have been used; some call for lower dosages initially with gradual increases as puberty progresses, with or without a decrease to maintenance levels. Other regimens call for higher dosage to induce pubertal changes and lower dosage for maintenance after puberty. The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose. Dosage is within the range of 50 to 200 mg every 2 to 4 weeks for a limited duration, for example, 4 to 6 months. X-rays should be taken at appropriate intervals to determine the amount of bone maturation and skeletal development (See INDICATIONS AND USAGE, and WARNINGS).
Palliation of Inoperable Mammary Cancer in Women:
A dosage of 200 to 400 mg every 2 to 4 weeks is recommended. Women with metastatic breast carcinoma must be followed closely because androgen therapy occasionally appears to accelerate the disease.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.
How is Testosterone Enanthate Supplied
Testosterone Enanthate Injection USP 200 mg/mL is available in 5 mL multiple dose vials, individually boxed.
Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Warming and shaking the vial will redissolve any crystals that may have formed during storage at low temperatures.
Literature revised: July 2010
Product Nos.: 0356-05
Manufactured by:
Hikma Farmaceutica (Portugal)
S.A. 2705-906 Terrugem SNT, Portugal
Distributed by:
Watson Pharma, Inc.
Corona, CA 92880 USA
PIN231-WAT/1
PRINCIPAL DISPLAY PANEL
NDC 0591-3221-26
5 mL Multiple Dose Vial
Testosterone
Enanthate
Injection USP
1,000 mg/5 mL
(200 mg/mL)
FOR INTRAMUSCULAR
USE ONLY
Watson Rx only
Sterile
Each mL contains:
Testosterone Enanthate
200 mg, with Chlorobutanol
(Chloral derivative) 0.5%
as preservative, in Sesame
Oil q.s.
Usual dosage:
See package insert for
full information.
Store at 20°-25°C
(68°-77°F)
[See USP Controlled
Room Temperature].
Manufactured by:
Hikma Farmaceutica (Portugal)
S.A. 2705-906 Terrugem SNT
Portugal
Distributed by:
Watson Pharma, Inc.
Corona, CA 92880 USA
| Testosterone Enanthate Testosterone Enanthate injection, solution | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA085598 | 05/04/2011 | |
| Labeler - Watson Laboratories, Inc. (966714656) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Hikma Farmaceutica | 452742943 | ANALYSIS, LABEL, MANUFACTURE, PACK | |
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Medazepam LFM
Medazepam LFM may be available in the countries listed below.
Ingredient matches for Medazepam LFM
Medazepam
Medazepam is reported as an ingredient of Medazepam LFM in the following countries:
- Hungary
International Drug Name Search
Fempress plus
Fempress plus may be available in the countries listed below.
Ingredient matches for Fempress plus
Hydrochlorothiazide
Hydrochlorothiazide is reported as an ingredient of Fempress plus in the following countries:
- Germany
Moexipril
Moexipril hydrochloride (a derivative of Moexipril) is reported as an ingredient of Fempress plus in the following countries:
- Germany
International Drug Name Search
Wednesday, September 28, 2016
Choline
In some countries, this medicine may only be approved for veterinary use.
In the US, Choline (choline salicylate/magnesium salicylate systemic) is a member of the drug class nutraceutical products.
US matches:
- Choline and Magnesium Trisalicylates
- Choline and Magnesium Trisalicylates Liquid
- Choline Magnesium Trisalicylate
- Choline and dexpanthenol
- Choline y dexpanthenol
- Choline Magnesium Trisalicylate Liquid
Scheme
DCF
CAS registry number (Chemical Abstracts Service)
0000062-49-7
Chemical Formula
C5-H14-N-O
Molecular Weight
104
Therapeutic Category
Choleretic
Chemical Names
2-Hydroxyethyltrimethylammonium
2-Hydroxy-N,N,N-trimethylanaminium
Ethanaminium, 2-hydroxy-N,N,N-trimethyl-
Foreign Names
- Cholin (German)
- Choline (French)
Generic Names
- Choline (OS: DCF)
- Colina cloruro (OS: DCIT)
- Choline (chlorure de) (PH: Ph. Franç. Xe édit)
- Choline Chloride (PH: USP 30)
- Colina cloruro (PH: F.U. VIII)
- Choline Dihydrogen Citrate (IS)
- Choline Bitartrate (IS)
- Choline Bitartrate (PH: USP 30)
Brand Names
- Cholisorb (Choline and Sorbitol (veterinary use))
Zootech, France - Auz (Choline and Cyproheptadine)
Unikid, India - Hépato (Choline and Sorbitol (veterinary use))
Véto-Centre, France - Cystichol (Choline and Cystine)
Bailleul, France - Chomelanum
Schur, Germany
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
Click for further information on drug naming conventions and International Nonproprietary Names.
Icar
In the US, Icar (carbonyl iron systemic) is a member of the drug class iron products and is used to treat Iron Deficiency Anemia.
US matches:
- Icar Suspension
- Icar
- Icar Prenatal
- Icar Prenatal Chewable Calcium
- Icar Prenatal Essential Omega-3
Ingredient matches for Icar
Iron Dextran
Iron Dextran is reported as an ingredient of Icar in the following countries:
- United States
International Drug Name Search
Acebutolol 100mg Capsules
1. Name Of The Medicinal Product
SECTRAL CAPSULES 100mg
or
ACEBUTOLOL 100mg CAPSULES
2. Qualitative And Quantitative Composition
The active component of SECTRAL Capsules 100mg / ACEBUTOLOL 100mg CAPSULES is:
Acebutolol hydrochloride 111.0mg (equivalent to 100mg of base).
For a full list of excipients, see section 6.1
3. Pharmaceutical Form
Hard gelatin capsules, the bodies being opaque yellowish-buff and the caps opaque white in colour. Length approximately 17mm, diameter of body approximately 6mm. Both body and cap are printed in black:
|
|
|
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The capsules contain a white or almost white powder.
4. Clinical Particulars
4.1 Therapeutic Indications
SECTRAL capsules 100 mg / ACEBUTOLOL 100mg CAPSULES are indicated for the following:
The management of all grades of hypertension, angina pectoris and the control of tachyarrhythmias.
4.2 Posology And Method Of Administration
Hypertension: Initial dosage of 400mg orally once daily at breakfast or 200mg orally twice daily. If response is not adequate within two weeks, dosage may be increased up to 400mg orally twice daily; if the hypertension is still not adequately controlled consideration should be given to adding a second antihypertensive agent such as the calcium antagonist nifedipine or small doses of a thiazide diuretic.
Angina pectoris: Initial dosage of 400mg orally once daily at breakfast or 200mg twice daily. In severe forms up to 300mg three times daily may be required. Up to 1200mg daily has been used.
Cardiac Arrhythmias: When given orally, an initial dose of 200mg is recommended. The daily dose requirement for long term anti arrhythmic activity should lie between 400 and 1200mg daily. The dose can be gauged by response, and better control may be achieved by divided doses rather than single doses. It may take up to three hours for maximal anti-arrhythmic effect to become apparent.
Elderly: There are no specific dosage recommendations for the elderly with normal glomerular filtration rate. Dose reduction is necessary if moderate to severe renal impairment is present (see Section 4.4)
Children: Paediatric dose has not been established.
For all indications, it is advised that the lowest recommended dosage be used initially.
4.3 Contraindications
Cardiogenic shock is an absolute contraindication. Extreme caution is required in patients with blood pressures of the order of 100/60 mmHg or below. SECTRAL/ACEBUTOLOL is also contraindicated in patients with second and third degree heart block, sick sinus syndrome, marked bradycardia (< 45-50 bpm), uncontrolled heart failure, metabolic acidosis, severe .peripheral circulatory disorders, hypersensitivity to acebutolol, any of the excipients or to beta blockers, and untreated phaeochromocytoma.
4.4 Special Warnings And Precautions For Use
Renal impairment is not a contraindication to the use of SECTRAL/ACEBUTOLOL which has both renal and non-renal excretory pathways. Some caution should be exercised when administering high doses to patients with severe renal failure as accumulation could possibly occur in these circumstances.
The dosage frequency should not exceed once daily in patients with renal impairment. As a guide, the dosage should be reduced by 50% when glomerular filtration rates are between 25-50ml/min and by 75% when they are below 25ml/min (see Section 4.2).
Drug-induced bronchospasm is usually at least partially reversible by the use of a suitable agonist.
Although cardio-selective beta blockers may have less effect on lung function than non-selective beta blockers as with all beta blockers they should be avoided in patients with obstructive airways disease unless there are compelling clinical reasons for their use. Where such reasons exist, cardio-selective β-blockers should be used with the utmost care (from Section 4.3).
Beta-blockers may induce bradycardia. In such cases, the dosage should be reduced.
They may be used with care in patients with controlled heart failure (see Section 4.3).
Use with caution in patients with Prinzmetal's angina.
Beta blockers may aggravate peripheral circulatory disorders. They may mask signs of thyrotoxicosis and hypoglycaemia. They should only be used in patients with phaeochromocytoma with comcomitant alpha-adrenoceptor therapy
Patients with known psoriasis should take beta-blockers only after careful consideration.
Beta-blockers may increase both the sensitivity towards allergens and the seriousness of anaphylactic reactions.
Withdrawal of treatment by beta blockers should be achieved by gradual dosage reduction; this is especially important in patients with ischaemic heart disease
When it has been decided to interrupt beta-blockade prior to surgery, therapy should be discontinued for at least 24 hours. Continuation of therapy reduces the risk of arrhythmias but the risk of hypotension may be increased. If treatment is continued, caution should be observed with the use of certain anaesthetic drugs. The patient may be protected against vagal reactions by intravenous administration of atropine.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Sectral/Acebutolol should not be used with Verapamil or within several days of Verapamil therapy (and vice versa). Use with great care with any other calcium antagonists, particularly Diltiazem.
Class I anti-arrhythmic drugs (such as disopyramide) and amiodarone may increase atrial conduction time and induce negative inotropic effects when used concomitantly with beta-blockers.
In patients with labile and insulin-dependent diabetes, the dosage of the hypoglycaemic agent (ie insulin or oral diabetic drugs) may need to be reduced. However beta-blockers have also been known to blunt the effect of glibenclamide. Beta-adrenergic blockade may also prevent the appearance of signs of hypoglycaemia (tachycardia, see Section 4.4).
Cross reactions due to displacement of other drugs from plasma protein binding sites are unlikely due to the low degree of plasma protein binding exhibited by acebutolol and diacetolol.
If a beta-blocker is used concurrently with clonidine the latter should not be withdrawn until several days after the former is discontinued.
Acebutolol may antagonize the effect of sympathomimetic and xanthine bronchodilators.
Concurrent use of digoxin and beta blockers may occasionally induce serious bradycardia. The anti-hypertensive effects of beta blockers may be attenuated by non-steroidal anti-inflammatory agents.
Concomitant administration of tricyclic antidepressants, barbiturates and phenothiazines as well as other anti-hypertensive agent- may increase the blood pressure lowering effect of beta-blockers.
There is a theoretical risk that concurrent administration of monoamine oxidase inhibitors and high doses of beta-blockers, even if they are cardio-selective can produce hypertension.
SECTRAL/ACEBUTOLOL therapy should be brought to the attention of the anaesthetist prior to general anaesthesia (see Section 4.4). If treatment is continued, special care should be taken when using anaesthetic agents causing myocardial depression such as ether, cyclopropane and trichlorethylene.
4.6 Pregnancy And Lactation
Pregnancy: SECTRAL/ACEBUTOLOL should not be administered to female patients during the first trimester of pregnancy unless the physician considers it essential. In such cases the lowest possible dose should be used.
Beta blockers administered in late pregnancy may give rise to bradycardia, hypoglycaemia and cardiac or pulmonary complications in the foetus/neonate.
Beta-blockers can reduce placental perfusion, which may result in intrauterine foetal death, immature and premature deliveries
Animal studies have shown no teratogenic hazard.
Lactation: Acebutolol and its active metabolite are excreted in breast milk and the half life of acebutolol in the neonate is double that in adults. The risks of hypoglycaemia and bradycardia occurring in the nursing infant have not been evaluated. Therefore, breast-feeding is not recommended during treatment.
4.7 Effects On Ability To Drive And Use Machines
As with all beta-blockers, dizziness or fatigue may occur occasionally. This should be taken into account when driving or operating machinery.
4.8 Undesirable Effects
SECTRAL/ACEBUTOLOL possesses antihypertensive effects but these are unlikely to be noted in normotensive subjects. The side-effects common to beta-blockade include: bradycardia, heart failure, a slowing of AV conduction or increase of an existing AV block, hypotension, gastrointestinal effects (such as nausea, vomiting and diarrhoea), cold and cyanotic extremities, paraesthesia, Raynaud's syndrome, intermittent claudication, confusion, dizziness, impaired vision, headaches, shortness of breath, nightmares, hallucinations, psychoses and depression, loss of libido and lethargy. The low lipid solubility and lack of accumulation in CNS tissues of acebutolol and its active metabolite reduce the likelihood of sleep disturbances, depression or other central effects and such occurrences are rare.
Pulmonary infiltration and pneumonitis appear to be rare but potentially serious complications of beta-blockade therapy. Cases of pneumonitis have been reported with acebutolol.
There have been reports of skin rashes and/or dry eyes associated with the use of beta-adrenoceptor blocking drugs. The reported incidence is small and in most cases the symptoms have cleared when treatment was withdrawn. Discontinuation of the drug should be considered in such cases.
Cessation of therapy with a beta-blocker should be gradual. (see Section 4.4)
Although some patients have developed anti-nuclear factor titres, the incidence of associated clinical symptoms is rare and when present, these clear promptly on discontinuation of treatment. Rare cases of a Lupus-like syndrome have been reported.
Bronchospasm has occurred rarely during treatment with acebutolol.
4.9 Overdose
In the event of excessive bradycardia or hypotension, 1mg atropine sulphate administered intravenously should be given without delay. If this is insufficient it should be followed by a slow intravenous injection of isoprenaline (5mcg per minute) with constant monitoring until a response occurs. In severe cases of self-poisoning with circulatory collapse unresponsive to atropine and catecholamines the intravenous injection of glucagon 10-20mg may produce a dramatic improvement. Cardiac pacing may be employed if bradycardia becomes severe.
Judicious use of vasopressors, diazepam, phenytoin, lidocaine, digoxin and bronchodilators should be considered depending on the presentation of the patient. Acebutolol can be removed from blood by haemodialysis. Other symptoms and signs of overdosage include cardiogenic shock, AV block, conduction defects, pulmonary oedema, depressed level of consciousness, bronchospasm, hypoglycaemia and rarely hyperkalaemia.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Mode of action: SECTRAL/ACEBUTOLOL is a beta adrenoceptor antagonist which is cardioselective, i.e. acts preferentially on beta-1 adrenergic receptors in the heart. Its principal effects are to reduce heart rate especially on exercise and to lower blood pressure in hypertensive subjects. SECTRAL/ACEBUTOLOL and its equally active metabolite, diacetolol have anti-arrhythmic activity, the combined plasma half-life of the active drug and metabolite being 7-10 hours. Both have partial agonist activity (PAA) also known as intrinsic sympathomimetic activity (ISA). This property ensures that some degree of stimulation of beta receptors is maintained. Under conditions of rest, this tends to balance the negative chronotropic and negative inotropic effects. SECTRAL/ACEBUTOLOL blocks the effects of excessive catecholamine stimulation resulting from stress.
5.2 Pharmacokinetic Properties
After oral administration, acebutolol is rapidly and almost completely absorbed. Absorption appears to be unaffected by the presence of food in the gut. There is rapid formation of a major equiactive metabolite, diacetolol, which possesses a similar pharmacological profile to acebutolol. Peak plasma concentrations of active material (i.e. acebutolol plus diacetolol) are achieved within 2-4 hours and the terminal plasma elimination half-life is around 8-10 hours. Because of biliary excretion and direct transfer across the gut wall from the systemic circulation to the gut lumen, more than 50% of an oral dose of SECTRAL/ACEBUTOLOL is recovered in the faeces with acebutolol and diacetolol in equal proportions; the rest of the dose is recovered in the urine, mainly as diacetolol. Both acebutolol and diacetolol are hydrophilic and exhibit poor penetration of the CNS.
5.3 Preclinical Safety Data
No particulars.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Starch Potato
Silica colloidal anhydrous (E551)
Magnesium Stearate (E572)
Capsule Shell
Body:
Yellow iron oxide (E172)
Titanium dioxide (E171)
Gelatin
Cap:
Titanium dioxide (E171)
Gelatin
Ink
Opacode S-1-8100 Black containing
shellac
Iron oxide (E172)
Lecithin
Antifoam DC 1501
6.2 Incompatibilities
Not applicable
6.3 Shelf Life
The shelf-life of SECTRAL Capsules 100mg / ACEBUTOLOL 100mg CAPSULES is 60 months.
6.4 Special Precautions For Storage
Store in a dry place below 25°C. Protect from light
6.5 Nature And Contents Of Container
Aluminium foil/UPVC blister strip packs of 84 tablets.
6.6 Special Precautions For Disposal And Other Handling
None
7. Marketing Authorisation Holder
Aventis Pharma Ltd
50 Kings Hill Avenue
Kings Hill
West Malling
Kent
ME19 4AH
United Kingdom
Trading as:-
Sanofi-aventis
One Onslow Street
Guildford
Surrey, GU1 4YS, UK
8. Marketing Authorisation Number(S)
PL 04425/0262
9. Date Of First Authorisation/Renewal Of The Authorisation
13th July 2001
10. Date Of Revision Of The Text
November 2006
LEGAL CLASSIFICATION
POM
Cetapred
Generic Name: sulfacetamide and prednisolone ophthalmic (SUL fa SEET a mide and pred NIS oh lone off THAL mik)
Brand Names: Blephamide, Blephamide S.O.P., Ocu-Lone C
What is Cetapred (sulfacetamide and prednisolone ophthalmic)?
Sulfacetamide is an antibiotic. It is used to treat bacterial infections.
Prednisolone is a steroid. It is used to treat the swelling associated with bacterial infections of the eye.
Sulfacetamide and prednisolone ophthalmic is used to treat bacterial infections of the eyes.
Sulfacetamide and prednisolone ophthalmic may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about Cetapred (sulfacetamide and prednisolone ophthalmic)?
Contact your doctor if your symptoms begin to get worse or if you do not see any improvement in your condition after a few days.
Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye.
Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear duct.
Who should not use Cetapred (sulfacetamide and prednisolone ophthalmic)?
Do not use sulfacetamide and prednisolone ophthalmic if you have a viral or fungal infection in your eye. It is used to treat infections caused by bacteria only.
Do not use sulfacetamide and prednisolone ophthalmic if you have ever had an allergic reaction to a sulfa-based drug.
It is not known whether sulfacetamide and prednisolone ophthalmic will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant. It is also not known whether sulfacetamide and prednisolone ophthalmic passes into breast milk. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.
How should I use Cetapred (sulfacetamide and prednisolone ophthalmic)?
Use sulfacetamide and prednisolone ophthalmic eyedrops or ointment exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Wash your hands before using your eyedrops or ointment.
To apply the eyedrops:
Shake the drops gently to be sure the medicine is well mixed. Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out a drop and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. If you are using more than one drop in the same eye or drops in both eyes, repeat the process with about 5 minutes between drops.
To apply the ointment:
Hold the tube in your hand for a few minutes to warm it up so that the ointment comes out easily. Tilt your head back slightly and pull down gently on your lower eyelid. Apply a thin film of the ointment into your lower eyelid. Close your eye and roll your eyeball around in all directions for 1 to 2 minutes. If you are applying another eye medication, allow at least 10 minutes before your next application.
Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye. Do not use any eyedrop that is discolored or has particles in it. Store sulfacetamide and prednisolone ophthalmic at room temperature away from moisture and heat. Keep the bottle or tube properly capped.
What happens if I miss a dose?
Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.
What happens if I overdose?
An overdose of this medication is unlikely to occur. If you do suspect an overdose, wash the eye with water and call an emergency room or poison control center near you. If the drops or ointment have been ingested, drink plenty of fluid and call an emergency center for advice.
What should I avoid while using Cetapred (sulfacetamide and prednisolone ophthalmic)?
Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye. Use caution when driving, operating machinery, or performing other hazardous activities. Sulfacetamide and prednisolone ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.
Use caution with contact lenses. Wear them only if your doctor approves. After applying this medication, wait at least 15 minutes before inserting contact lenses.
Avoid other eye medications unless your doctor approves.
Cetapred (sulfacetamide and prednisolone ophthalmic) side effects
Serious side effects are not expected with this medication.
Some burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Cetapred (sulfacetamide and prednisolone ophthalmic)?
Do not use this medication with other eyedrops that contain nitrates (e.g., silver nitrate).
Avoid other eye medications unless they are approved by your doctor.
Before using this medication, tell your doctor if you are taking an oral steroid medication such as prednisone (Deltasone, Orasone, others).
Drugs other than those listed here may also interact with sulfacetamide and prednisolone ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.
More Cetapred resources
- Cetapred Side Effects (in more detail)
- Cetapred Use in Pregnancy & Breastfeeding
- Cetapred Drug Interactions
- Cetapred Support Group
- 0 Reviews for Cetapred - Add your own review/rating
- Blephamide Prescribing Information (FDA)
- Blephamide Suspension MedFacts Consumer Leaflet (Wolters Kluwer)
- Blephamide S.O.P. Ointment MedFacts Consumer Leaflet (Wolters Kluwer)
- Vasocidin Prescribing Information (FDA)
- Vasocidin Drops MedFacts Consumer Leaflet (Wolters Kluwer)
Compare Cetapred with other medications
- Blepharitis
- Conjunctivitis, Bacterial
- Keratitis
- Keratoconjunctivitis
- Uveitis
Where can I get more information?
- Your pharmacist has additional information about sulfacetamide and prednisolone ophthalmic written for health professionals that you may read.
See also: Cetapred side effects (in more detail)
Tuesday, September 27, 2016
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