Cemin may be available in the countries listed below.
Ingredient matches for Cemin
Ascorbic Acid
Ascorbic Acid is reported as an ingredient of Cemin in the following countries:
- Ecuador
International Drug Name Search
Wednesday, 28 September 2016
Napsyn
Napsyn may be available in the countries listed below.
Ingredient matches for Napsyn
Naproxen
Naproxen is reported as an ingredient of Napsyn in the following countries:
- Slovakia
International Drug Name Search
Sucralfate
Sucralfate is an α-D-glucopyranoside, β-D-fructofuranosyl-, octakis(hydrogen sulfate), aluminum complex.
R = SO3Al(OH)2
Tablets for oral administration contain 1 g of Sucralfate.
Inactive Ingredients
Corn starch, magnesium stearate, and microcrystalline cellulose
Therapeutic Category
antiulcer
Sucralfate - Clinical Pharmacology
Sucralfate is only minimally absorbed from the gastrointestinal tract. The small amounts of the sulfated disaccharide that are absorbed are excreted primarily in the urine.
Although the mechanism of Sucralfate’s ability to accelerate healing of duodenal ulcers remains to be fully defined, it is known that it exerts its effect through a local, rather than systemic, action. The following observations also appear pertinent:
- Studies in human subjects and with animal models of ulcer disease have shown that Sucralfate forms an ulcer-adherent complex with proteinaceous exudate at the ulcer site.
- In vitro, a Sucralfate-albumin film provides a barrier to diffusion of hydrogen ions.
- In human subjects, Sucralfate given in doses recommended for ulcer therapy inhibits pepsin activity in gastric juice by 32%.
- In vitro, Sucralfate absorbs bile salts.
These observations suggest that Sucralfate’s antiulcer activity is the result of formation of an ulcer-adherent complex that covers the ulcer site and protects it against further attack by acid, pepsin, and bile salts. There are approximately 14 to 16 mEq of acid-neutralizing capacity per 1 g dose of Sucralfate.
Clinical Trials
Acute Duodenal Ulcer
Over 600 patients have participated in well-controlled clinical trials worldwide. Multicenter trials conducted in the United States, both of them placebo-controlled studies with endoscopic evaluation at 2 and 4 weeks, showed:
| Treatment Groups | Ulcer Healing/No. Patients | |
| 2 wk | 4 wk (Overall) | |
| Sucralfate | 37/105 (35.2%) | 82/109 (75.2%) |
| Placebo | 26/106 (24.5%) | 68/107 (63.6%) |
| Treatment Groups | Ulcer Healing/No. Patients | |
| 2 wk | 4 wk (Overall) | |
| Sucralfate | 8/24 (33%) | 22/24 (92%) |
| Placebo | 4/31 (13%) | 18/31 (58%) |
The Sucralfate-placebo differences were statistically significant in both studies at 4 weeks but not at 2 weeks. The poorer result in the first study may have occurred because Sucralfate was given 2 hours after meals and at bedtime rather than 1 hour before meals and at bedtime, the regimen used in international studies and in the second United States study. In addition, in the first study liquid antacid was utilized as needed, whereas in the second study antacid tablets were used.
Maintenance Therapy After Healing of Duodenal Ulcer
Two double-blind randomized placebo-controlled U.S. multicenter trials have demonstrated that Sucralfate (1 g bid) is effective as maintenance therapy following healing of duodenal ulcers.
In one study, endoscopies were performed monthly for 4 months. Of the 254 patients who enrolled, 239 were analyzed in the intention-to-treat life table analysis presented below.
| |||||
| Months of Therapy | |||||
| Drug | n | 1 | 2 | 3 | 4 |
| Sucralfate | 122 | 20* | 30* | 38† | 42† |
| Placebo | 117 | 33 | 46 | 55 | 63 |
In this study, prn antacids were not permitted.
In the other study, scheduled endoscopies were performed at 6 and 12 months, but for-cause endoscopies were permitted as symptoms dictated. Median symptom scores between the Sucralfate and placebo groups were not significantly different. A life table intention-to-treat analysis for the 94 patients enrolled in the trial had the following results:
| |||
| Drug | n | 6 months | 12 months |
| Sucralfate | 48 | 19* | 27* |
| Placebo | 46 | 54 | 65 |
In this study, prn antacids were permitted.
Data from placebo-controlled studies longer than 1 year are not available.
Indications and Usage for Sucralfate
Sucralfate is indicated in:
- Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with Sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.
- Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.
Contraindications
There are no known contraindications to the use of Sucralfate.
Precautions
Duodenal ulcer is a chronic, recurrent disease. While short-term treatment with Sucralfate can result in complete healing of the ulcer, a successful course of treatment with Sucralfate should not be expected to alter the posthealing frequency or severity of duodenal ulceration.
Special Populations
Chronic Renal Failure and Dialysis Patients
When Sucralfate is administered orally, small amounts of aluminum are absorbed from the gastrointestinal tract. Concomitant use of Sucralfate with other products that contain aluminum, such as aluminum-containing antacids, may increase the total body burden of aluminum. Patients with normal renal function receiving the recommended doses of Sucralfate and aluminum-containing products adequately excrete aluminum in the urine. Patients with chronic renal failure or those receiving dialysis have impaired excretion of absorbed aluminum. In addition, aluminum does not cross dialysis membranes because it is bound to albumin and transferrin plasma proteins. Aluminum accumulation and toxicity (aluminum osteodystrophy, osteomalacia, encephalopathy) have been described in patients with renal impairment. Sucralfate should be used with caution in patients with chronic renal failure.
Drug Interactions
Some studies have shown that simultaneous Sucralfate administration in healthy volunteers reduced the extent of absorption (bioavailability) of single doses of the following: cimetidine, digoxin, fluoroquinolone antibiotics, ketoconazole, l-thyroxine, phenytoin, quinidine, ranitidine, tetracycline, and theophylline. Subtherapeutic prothrombin times with concomitant warfarin and Sucralfate therapy have been reported in spontaneous and published case reports. However, two clinical studies have demonstrated no change in either serum warfarin concentration or prothrombin time with the addition of Sucralfate to chronic warfarin therapy.
The mechanism of these interactions appears to be nonsystemic in nature, presumably resulting from Sucralfate binding to the concomitant agent in the gastrointestinal tract. In all case studies to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing the concomitant medication 2 hours before Sucralfate eliminated the interaction. Because of the potential of Sucralfate to alter the absorption of some drugs, Sucralfate should be administered separately from other drugs when alterations in bioavailability are felt to be critical. In these cases, patients should be monitored appropriately.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Chronic oral toxicity studies of 24 months’ duration were conducted in mice and rats at doses up to 1 g/kg (12 times the human dose).
There was no evidence of drug-related tumorigenicity. A reproduction study in rats at doses up to 38 times the human dose did not reveal any indication of fertility impairment. Mutagenicity studies were not conducted.
Pregnancy
Teratogenic Effects
Pregnancy category B
Teratogenicity studies have been performed in mice, rats, and rabbits at doses up to 50 times the human dose and have revealed no evidence of harm to the fetus due to Sucralfate. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sucralfate is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in children have not been established.
Geriatric Use
Clinical studies of Sucralfate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. (See DOSAGE ANDADMINISTRATION.)
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. (See PRECAUTIONS, SpecialPopulations, Chronic Renal Failureand Dialysis Patients.) Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Adverse Reactions
Adverse reactions to Sucralfate in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 patients treated with Sucralfate tablets, adverse effects were reported in 129 (4.7%).
Constipation was the most frequent complaint (2%). Other adverse effects reported in less than 0.5% of the patients are listed below by body system:
Gastrointestinal
diarrhea, nausea, vomiting, gastric discomfort, indigestion, flatulence, dry mouth
Dermatological
pruritus, rash
Nervous System
dizziness, insomnia, sleepiness, vertigo
Other
back pain, headache
Postmarketing reports of hypersensitivity reactions, including urticaria (hives), angioedema, respiratory difficulty, rhinitis, laryngospasm, and facial swelling have been reported in patients receiving Sucralfate tablets. Similar events were reported with Sucralfate suspension. However, a causal relationship has not been established.
Bezoars have been reported in patients treated with Sucralfate. The majority of patients had underlying medical conditions that may predispose to bezoar formation (such as delayed gastric emptying) or were receiving concomitant enteral tube feedings.
Inadvertent injection of insoluble Sucralfate and its insoluble excipients has led to fatal complications, including pulmonary and cerebral emboli. Sucralfate is not intended for intravenous administration.
Overdosage
Due to limited experience in humans with overdosage of Sucralfate, no specific treatment recommendations can be given. Acute oral toxicity studies in animals, however, using doses up to 12 g/kg body weight, could not find a lethal dose. Sucralfate is only minimally absorbed from the gastrointestinal tract. Risks associated with acute overdosage should, therefore, be minimal. In rare reports describing Sucralfate overdose, most patients remained asymptomatic. Those few reports where adverse events were described included symptoms of dyspepsia, abdominal pain, nausea, and vomiting.
Sucralfate Dosage and Administration
Active Duodenal Ulcer
The recommended adult oral dosage for duodenal ulcer is 1 g four times per day on an empty stomach.
Antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or after Sucralfate.
While healing with Sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.
Maintenance Therapy
The recommended adult oral dosage is 1 g twice a day.
Elderly
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. (See PRECAUTIONS, Geriatric Use.)
How is Sucralfate Supplied
Sucralfate tablets, USP are supplied as white, single-scored, capsule-shaped tablets containing 1 gram of Sucralfate. Available in bottles of 90, 100 and 500 and in unit-dose boxes of 100 (10 x 10s). Tablets are debossed “BIOCRAFT” on one side and “105” twice on the scored side.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. H 12/2009
Principal Display Panel
Sucralfate Tablets 1 gram 90s Label Text
NDC 0093-2210-98
Sucralfate
Tablets, USP
1 gram
Rx only
90 TABLETS
TEVA
| Sucralfate Sucralfate tablet | ||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||
| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA070848 | 07/27/2010 | |
| Labeler - TEVA Pharmaceuticals USA Inc (118234421) |
More Sucralfate resources
- Sucralfate Side Effects (in more detail)
- Sucralfate Dosage
- Sucralfate Use in Pregnancy & Breastfeeding
- Drug Images
- Sucralfate Drug Interactions
- Sucralfate Support Group
- 16 Reviews for Sucralfate - Add your own review/rating
- Sucralfate Professional Patient Advice (Wolters Kluwer)
- Sucralfate MedFacts Consumer Leaflet (Wolters Kluwer)
- Sucralfate Monograph (AHFS DI)
- sucralfate Advanced Consumer (Micromedex) - Includes Dosage Information
- Carafate Consumer Overview
Compare Sucralfate with other medications
- Duodenal Ulcer
- Duodenal Ulcer Prophylaxis
- GERD
- Hyperphosphatemia of Renal Failure
- Stomach Ulcer
- Stomatitis
- Stress Ulcer Prophylaxis
Tuesday, 27 September 2016
YF-Vax
Pronunciation: YEL-oh FEEV-er
Generic Name: Yellow Fever Vaccine
Brand Name: YF-Vax
YF-Vax is used for:
Immunizing against yellow fever infections for those traveling or living in an area with risk of infection.
YF-Vax is a vaccine. It works by stimulating the body to create antibodies, which provide protection from yellow fever infection.
Do NOT use YF-Vax if:
- you are allergic to any ingredient in YF-Vax or latex rubber
- you are allergic to eggs, egg products, or chicken protein
- you have a weakened immune system due to HIV or cancer or are receiving radiation treatment or chemotherapy (eg, alkylating drugs, corticosteroids)
Contact your doctor or health care provider right away if any of these apply to you.
Before using YF-Vax:
Some medical conditions may interact with YF-Vax. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
Some MEDICINES MAY INTERACT with YF-Vax. However, no specific interactions with YF-Vax are known at this time.
This may not be a complete list of all interactions that may occur. Ask your health care provider if YF-Vax may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use YF-Vax:
Use YF-Vax as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- YF-Vax is administered as an injection at the doctor's office, hospital, or a clinic. Ask your doctor or pharmacist any questions that you may have about YF-Vax.
- An International Certificate of Vaccination should be given with this vaccine and may need to be shown as documentation when traveling to certain countries.
- If you miss a dose of YF-Vax, contact your doctor immediately.
Ask your health care provider any questions you may have about how to use YF-Vax.
Important safety information:
- Keep all doctor and lab appointments while using YF-Vax.
- If you have a fever, illness, or infection, your doctor may delay giving the vaccine. Discuss this with your doctor.
- It will take 10 days for the full protection of this vaccine to take effect. A booster is recommended every 10 years.
- Do not rely on this vaccine alone. Ask your doctor about preventative measures that can be taken to avoid exposure to yellow fever.
- YF-Vax is not recommended for use in INFANTS younger than 9 months of age because there is a higher risk of swelling in the brain.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using YF-Vax during pregnancy. It is unknown if YF-Vax is excreted in breast milk. If you are or will be breast-feeding while you are using YF-Vax, check with your doctor or pharmacist to discuss the risks to your baby.
Possible side effects of YF-Vax:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Fever; mild headache; muscle aches; pain, swelling, and hardness at the injection site.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); swelling in the brain.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: YF-Vax side effects (in more detail)
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of YF-Vax:
Store YF-Vax at a constant temperature in the freezer, at 32 to 41 degrees F (0 to 5 degrees C). Do not refreeze. Keep YF-Vax out of the reach of children and away from pets.
General information:
- If you have any questions about YF-Vax, please talk with your doctor, pharmacist, or other health care provider.
- YF-Vax is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information is a summary only. It does not contain all information about YF-Vax. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: February 1, 2012
Database Edition 12.1.1.002
Copyright © 2012 Wolters Kluwer Health, Inc.
More YF-Vax resources
- YF-Vax Side Effects (in more detail)
- YF-Vax Use in Pregnancy & Breastfeeding
- YF-Vax Drug Interactions
- YF-Vax Support Group
- 0 Reviews for YF-Vax - Add your own review/rating
- YF-Vax Prescribing Information (FDA)
- YF-Vax Concise Consumer Information (Cerner Multum)
- Yellow Fever Vaccine Professional Patient Advice (Wolters Kluwer)
- YF-VAX Monograph (AHFS DI)
- Yf-Vax Advanced Consumer (Micromedex) - Includes Dosage Information
Compare YF-Vax with other medications
- Yellow Fever Prophylaxis
Supositorios de Glicerina Fecofar
Supositorios de Glicerina Fecofar may be available in the countries listed below.
Ingredient matches for Supositorios de Glicerina Fecofar
Glycerol
Glycerol is reported as an ingredient of Supositorios de Glicerina Fecofar in the following countries:
- Argentina
International Drug Name Search
Yasmin
Generic Name: drospirenone and ethinyl estradiol (Oral route)
droe-SPYE-re-none, ETH-i-nil es-tra-DYE-ol
Oral route(Tablet)
Cigarette smoking increases the risk of serious cardiovascular events from oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. Women who are over 35 years of age and smoke should not use oral contraceptives .
Commonly used brand name(s)
In the U.S.
- Gianvi
- Loryna
- Ocella
- Syeda
- Vestura
- Yasmin
- YAZ
- Yaz 28
- Zarah
Available Dosage Forms:
- Tablet
Therapeutic Class: Monophasic Contraceptive Combination
Pharmacologic Class: Progestin
Uses For Yasmin
Drospirenone and ethinyl estradiol combination is used as an oral contraceptive. Oral contraceptives are known also as the Pill, OCs, BCs, BC tablets, or birth control pills. This medicine usually contains two types of hormones, estrogens and progestins and, when taken properly, prevents pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented. Although oral contraceptives have other effects that help prevent a pregnancy from occurring, this is the main action.
This medicine is also used to treat premenstrual dysphoric disorder (PMDD). PMDD is a severe form of premenstrual syndrome (PMS). Patients with PMDD may experience severe emotional and physical symptoms 10 to 14 days before their menstrual flow starts .
No contraceptive method is 100 percent effective. Discuss with your health care professional your options for birth control .
Drospirenone and ethinyl estradiol combination is also used to treat acne in women at least 14 years of age, who have already started menstruating and choose to use a birth control pill to prevent pregnancy .
This medicine is available only with your doctor's prescription.
Before Using Yasmin
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 this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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
This medicine is not intended for use in children or teenagers who have not yet started menstruating. This medicine is frequently used for birth control in teenage females and has not been shown to cause different side effects or problems than it does in adults. Some teenagers may need extra information on the importance of taking this medication exactly as prescribed.
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | X | Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit. |
Breast Feeding
Drospirenone
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
Ethinyl Estradiol
Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.
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 this medicine, 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 this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Boceprevir
Using this medicine 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.
- Boceprevir
- Felbamate
- Isotretinoin
- Paclitaxel
- Paclitaxel Protein-Bound
- Theophylline
- Tizanidine
- Tranexamic Acid
Using this medicine 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.
- Alprazolam
- Amoxicillin
- Ampicillin
- Amprenavir
- Aprepitant
- Atazanavir
- Bacampicillin
- Betamethasone
- Bexarotene
- Bosentan
- Carbamazepine
- Colesevelam
- Cyclosporine
- Darunavir
- Delavirdine
- Doxycycline
- Efavirenz
- Etravirine
- Fosamprenavir
- Fosaprepitant
- Fosphenytoin
- Ginseng
- Griseofulvin
- Lamotrigine
- Licorice
- Minocycline
- Modafinil
- Mycophenolate Mofetil
- Mycophenolic Acid
- Nelfinavir
- Nevirapine
- Oxcarbazepine
- Oxytetracycline
- Phenobarbital
- Phenytoin
- Pioglitazone
- Prednisolone
- Primidone
- Rifabutin
- Rifampin
- Rifapentine
- Ritonavir
- Roflumilast
- Rosuvastatin
- Rufinamide
- Selegiline
- St John's Wort
- Telaprevir
- Tetracycline
- Tipranavir
- Topiramate
- Troglitazone
- Troleandomycin
- Valdecoxib
- Voriconazole
- Warfarin
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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Caffeine
- Grapefruit Juice
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Abnormal changes in menstrual or uterine bleeding or
- Fibroid tumors of the uterus—Oral contraceptives usually improve these female conditions but sometimes they can make them worse or make the diagnosis of these problems more difficult.
- Adrenal insufficiency or
- Liver problems or
- Kidney problems—These conditions may increase the risk of retaining too much potassium in the blood.
- Blood clots (or history of) or
- Heart or circulation disease or
- Stroke (or history of)—If these conditions are already present, oral contraceptives may have a greater chance of causing blood clots or circulation problems, especially in women who smoke tobacco. Otherwise, oral contraceptives may help prevent circulation and heart disease if you are healthy and do not smoke.
- Cancer, including breast cancer (or history of or family history of)—Oral contraceptives may worsen some cancers, especially when breast, cervical, or uterine cancers already exist. Use of oral contraceptives is not recommended if you have any of these conditions. If you have a family history of breast disease, oral contraceptives may still be a good choice but you may need to be tested more often.
- Gallbladder disease or gallstones (or history of) or
- High blood cholesterol or
- High blood potassium or
- Liver disease (or history of, including jaundice during pregnancy) or
- Mental depression (or history of)—Oral contraceptives may make these conditions worse or, rarely, cause them to occur again. Oral contraceptives may still be a good choice but you may need to be tested more often.
- High blood pressure (hypertension) or
- Migraine headaches—Oral contraceptives may cause fluid build-up and may cause these conditions to become worse; however, some people have fewer migraine headaches when they use oral contraceptives.
Proper Use of drospirenone and ethinyl estradiol
This section provides information on the proper use of a number of products that contain drospirenone and ethinyl estradiol. It may not be specific to Yasmin. Please read with care.
Make certain your health care professional knows if you are on any special diet, such as a low-sodium or low-sugar diet.
To make using oral contraceptives as safe and reliable as possible, you should understand how and when to take them and what effects may be expected.
A paper with information for the patient will be given to you with your filled prescription, and will provide many details concerning the use of oral contraceptives. Read this paper carefully and ask your health care professional if you need additional information or explanation.
When you begin to use oral contraceptives, your body will require at least 7 days to adjust before a pregnancy will be prevented. You will need to use an additional birth control method for at least 7 days. Some doctors recommend using an additional method of birth control for the first cycle (or 3 weeks) to ensure full protection. Follow the advice of your doctor or other health care professional.
Try to take the doses no more than 24 hours apart to reduce the possibility of side effects and to prevent pregnancy. Since one of the most important factors in the proper use of oral contraceptives is taking every dose exactly on schedule, you should never let your tablet supply run out. When possible, try to keep an extra month's supply of tablets on hand and replace it monthly.
It is very important that you keep the tablets in their original container and take the tablets in the same order that they appear in the container. The containers help you keep track of which tablets to take next. Different colored tablets in the same package contain different amounts of hormones or are placebos (tablets that do not contain hormones). The effectiveness of the medicine is reduced if the tablets are taken out of order.
Dosing
The dose of this medicine 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 this medicine. 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.
Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 start) or on Sunday after your period starts (called Sunday start). When you begin on a certain day it is important that you follow that schedule, even when you miss a dose. Do not change your schedule on your own. If the schedule that you have been put on is not convenient, check with your doctor about changing schedules. For Sunday start you need to use another form of birth control for the first 7 days.
For Yasmin(R) and Yaz(R), begin next and all subsequent 28-day regimens of therapy on the same day of the week as the first regimen began and follow the same schedule .
- For oral dosage form (tablets):
- For contraception or treatment of acne:
- Adults and teenagers (after menarche) — Yasmin(R), 1 yellow tablet by mouth every day for 21 consecutive days followed by 1 white (inert) tablet daily for 7 days per menstrual cycle
- Adults and teenagers (after menarche)— Yaz(R), 1 pink tablet by mouth every day for 24 consecutive days followed by 1 white (inert) tablet daily for 4 days per menstrual cycle
- For contraception or treatment of acne:
Missed Dose
Call your doctor or pharmacist for instructions.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Precautions While Using Yasmin
It is very important that your doctor check your progress at regular visits to make sure this medicine does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors require them more often.
This medicine will not protect you from getting HIV/AIDS or other sexually transmitted diseases. If this is a concern for you, talk with your doctor .
Tell the medical doctor or dentist in charge that you are taking this medicine before any kind of surgery (including dental surgery) or emergency treatment. Your doctor will decide whether you should continue taking this medicine .
Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier. If this should occur:
- Continue on your regular dosing schedule.
- The bleeding usually stops within 1 week.
- Check with your doctor if the bleeding continues for more than 1 week.
- After you have been taking oral contraceptives on schedule and for more than 3 months and bleeding continues, check with your doctor.
Missed menstrual periods may occur:
- If you have not taken the medicine exactly as scheduled. Pregnancy must be considered as a possibility.
- If the medicine is not the right strength or type for your needs.
- If you stop taking oral contraceptives, especially if you have taken oral contraceptives for 2 or more years.
Check with your doctor if you miss any menstrual periods so that the cause may be determined.
If you suspect that you may have become pregnant, stop taking this medicine immediately and check with your doctor.
If you are scheduled for any laboratory tests, tell your doctor that you are taking birth control pills.
Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.
Check with your doctor immediately if you wear contact lenses or if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor) .
Yasmin Side Effects
Healthy women who do not smoke cigarettes have almost no chance of having a severe side effect from taking oral contraceptives. For most women, more problems occur because of pregnancy than will occur from taking oral contraceptives. But for some women who have special health problems, oral contraceptives can cause some unwanted effects. Some of these unwanted effects include benign (not cancerous) liver tumors, liver cancer, or blood clots or related problems, such as a stroke. Although these effects are very rare, they can be serious enough to cause death. You may want to discuss these effects with your doctor.
Smoking cigarettes during the use of oral contraceptives has been found to greatly increase the chances of these serious side effects occurring. To reduce the risk of serious side effects, do not smoke cigarettes while you are taking oral contraceptives.
Check with your doctor immediately if any of the following side effects occur:
Rare
- Abdominal or stomach pain (sudden, severe, or continuing)
- anxiety
- burning pain in lower abdomen
- changes in skin color
- chill
- convulsions
- coughing up blood
- feeling of heat
- feeling of warmth in lips and tongue
- fever
- headache (severe or sudden)
- loss of coordination (sudden)
- loss of vision or change in vision (sudden)
- nervousness
- numbness of the fingertips
- pain in lower back, pelvis, or stomach
- pains in chest, groin, or leg (especially in calf of leg)
- ringing in the ears
- shortness of breath (sudden or unexplained)
- slurring of speech (sudden)
- sudden loss of consciousness
- swelling of foot or leg
- weakness, numbness, or pain in arm or leg (unexplained)
Check with your doctor as soon as possible if any of the following side effects occur:
More common—usually less common after the first 3 months of oral contraceptive use
- Changes in the uterine bleeding pattern at menses or between menses, such as decreased bleeding at menses, breakthrough bleeding or spotting between periods, prolonged bleeding at menses, complete stopping of menstrual bleeding that occurs over several months in a row, or stopping of menstrual bleeding that only occurs sometimes.
- Headaches or migraines (although headaches may lessen in many users, in others, they may increase in number or become worse)
- increased blood pressure
- vaginal infection with vaginal itching or irritation, or thick, white, or curd-like discharge
- Pains in stomach, side, or abdomen
- yellow eyes or skin
- Lumps in breast
- Mental depression
- swelling, pain, or tenderness in upper abdominal area
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
- Abdominal cramping or bloating
- acne (usually less common after first 3 months and may improve if acne already exists)
- breast pain, tenderness, or swelling
- dizziness
- nausea
- swelling of ankles and feet
- unusual tiredness or weakness
- vomiting
- Brown, blotchy spots on exposed skin
- gain or loss of body or facial hair
- increased or decreased interest in sexual intercourse
- weight gain or loss
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: Yasmin 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 Yasmin resources
- Yasmin Side Effects (in more detail)
- Yasmin Use in Pregnancy & Breastfeeding
- Drug Images
- Yasmin Drug Interactions
- Yasmin Support Group
- 46 Reviews for Yasmin - Add your own review/rating
- Yasmin Consumer Overview
- Yasmin MedFacts Consumer Leaflet (Wolters Kluwer)
- Yasmin Prescribing Information (FDA)
- Gianvi Prescribing Information (FDA)
- Loryna Prescribing Information (FDA)
- Ocella Prescribing Information (FDA)
- Syeda Prescribing Information (FDA)
- YAZ MedFacts Consumer Leaflet (Wolters Kluwer)
- Yaz Prescribing Information (FDA)
- Yaz Consumer Overview
- Zarah Prescribing Information (FDA)
Compare Yasmin with other medications
- Acne
- Birth Control
- Menstrual Disorders
- Premenstrual Dysphoric Disorder
Monday, 26 September 2016
Alosetron
Pronunciation: a-LOE-se-tron
Generic Name: Alosetron
Brand Name: Lotronex
Serious intestinal problems, which may be life-threatening, have occurred with Alosetron. These problems may lead to hospitalization and, in some cases, blood transfusions, surgery, and even death.
Stop taking Alosetron and contact your doctor at once if you develop constipation. If constipation occurs, Alosetron should only be restarted on the advice of your doctor.
Stop taking Alosetron and contact your doctor at once if you experience rectal bleeding, bloody diarrhea, bloody stools, or new or worsening abdominal pain. These could be signs of a condition called ischemic colitis, in which the blood flow to parts of your intestine is reduced. If this condition occurs, Alosetron should not be restarted.
After discussing Alosetron with your doctor, you must read, initial, and sign a consent form before taking Alosetron. Do not sign the consent form if there is anything you do not understand.
Alosetron is used for:
Treating women with severe irritable bowel syndrome (IBS) accompanied by severe diarrhea (usually lasting for 6 months or more). It is only prescribed to women who do not respond to other medicines and is not to be used by women whose main IBS problem is constipation. Certain stomach or intestinal disorders must be ruled out before Alosetron is prescribed.
Alosetron is a selective 5-HT3 receptor antagonist. It works by blocking the action of serotonin on the intestinal system. This reduces the cramping, stomach pain, stomach discomfort, urgency, and diarrhea caused by IBS.
Do NOT use Alosetron if:
- you are allergic to any ingredient in Alosetron
- you are constipated, you have a history of severe or long-term constipation, or your main IBS problem is constipation
- you have a history of blood flow problems to your intestine or bowels (eg, ischemic colitis)
- you have a history of severe liver problems, blood-clotting, or circulation problems; blood vessel inflammation; Crohn disease; diverticulitis; enlarged colon; perforation of the stomach, intestine, or bowel; paralysis of the intestinal tract; narrowing, growths, or scarring of the intestine; blockage of the bowel or intestine; or ulcerative colitis
- you are unable to understand or follow the patient-physician agreement for Alosetron
- you are taking fluvoxamine
Contact your doctor or health care provider right away if any of these apply to you.
Before using Alosetron:
Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have liver problems or rectal bleeding
- if you have very poor health
Some MEDICINES MAY INTERACT with Alosetron. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Cimetidine, clarithromycin, fluvoxamine, HIV protease inhibitors (eg, ritonavir), imidazole antifungals (eg, itraconazole, ketoconazole), quinolone antibiotics (eg, ciprofloxacin), telithromycin, or voriconazole because they may increase the risk of Alosetron's side effects
This may not be a complete list of all interactions that may occur. Ask your health care provider if Alosetron may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Alosetron:
Use Alosetron as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Alosetron comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Alosetron refilled.
- Take Alosetron by mouth with or without food.
- Your doctor will fully counsel you on the risks and benefits of taking Alosetron before your prescription is written. You must sign a consent form stating you will follow your doctor's instructions before you can take Alosetron.
- Your pharmacist cannot fill your prescription unless it has a program sticker attached to it.
- Alosetron works best if it is taken at the same time each day.
- If you miss a dose of Alosetron, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Alosetron.
Important safety information:
- It may take up to 4 weeks for Alosetron to work. Contact your doctor if you have not experienced any improvement in your condition after 4 weeks.
- Tell your doctor or dentist that you take Alosetron before you receive any medical or dental care, emergency care, or surgery.
- Use Alosetron with caution in the ELDERLY; they may be more sensitive to its effects, especially constipation, if it occurs.
- Alosetron should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Alosetron while you are pregnant. It is not known if Alosetron is found in breast milk. If you are or will be breast-feeding while you are using Alosetron, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Alosetron:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Nausea; mild stomach discomfort and pain.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloating; bloody diarrhea; bloody stools; constipation; mental or mood changes; new or worsening stomach discomfort or pain; rectal bleeding; severe or persistent nausea; unexplained fever; unusually fast pulse; vomiting.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Alosetron side effects (in more detail)
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include loss of coordination; seizures; tremors; trouble breathing.
Proper storage of Alosetron:
Store Alosetron at 77 degrees F (25 degrees C) in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Alosetron out of the reach of children and away from pets.
General information:
- If you have any questions about Alosetron, please talk with your doctor, pharmacist, or other health care provider.
- Alosetron is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information is a summary only. It does not contain all information about Alosetron. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: February 1, 2012
Database Edition 12.1.1.002
Copyright © 2012 Wolters Kluwer Health, Inc.
More Alosetron resources
- Alosetron Side Effects (in more detail)
- Alosetron Use in Pregnancy & Breastfeeding
- Alosetron Drug Interactions
- Alosetron Support Group
- 10 Reviews for Alosetron - Add your own review/rating
- alosetron Advanced Consumer (Micromedex) - Includes Dosage Information
- Alosetron Hydrochloride Monograph (AHFS DI)
- Lotronex Prescribing Information (FDA)
- Lotronex Consumer Overview
Compare Alosetron with other medications
- Diarrhea
- Irritable Bowel Syndrome
Subscribe to:
Comments (Atom)