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п»їAvapro


Generic Name: irbesartan
Dosage Form: Tablets
Use in Pregnancy

When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, Avapro should be discontinued as soon as possible. See WARNINGS: Fetal/Neonatal Morbidity and Mortality.
Avapro Description

AvaproВ®* (irbesartan) is an angiotensin II receptor (AT1 subtype) antagonist.

*Registered trademark

Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one.

Its empirical formula is C25H28N6O, and the structural formula:

Irbesartan is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water.

Avapro is available for oral administration in unscored tablets containing 75 mg, 150 mg, or 300 mg of irbesartan. Inactive ingredients include: lactose, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, poloxamer 188, silicon dioxide and magnesium stearate.
Avapro - Clinical Pharmacology
Mechanism of Action

Angiotensin II is a potent vasoconstrictor formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system (RAS) and also stimulates aldosterone synthesis and secretion by adrenal cortex, cardiac contraction, renal resorption of sodium, activity of the sympathetic nervous system, and smooth muscle cell growth. Irbesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively binding to the AT1 angiotensin II receptor. There is also an AT2 receptor in many tissues, but it is not involved in cardiovascular homeostasis.

Irbesartan is a specific competitive antagonist of AT1 receptors with a much greater affinity (more than 8500-fold) for the AT1 receptor than for the AT2 receptor and no agonist activity.

Blockade of the AT1 receptor removes the negative feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and circulating angiotensin II do not overcome the effects of irbesartan on blood pressure.

Irbesartan does not inhibit ACE or renin or affect other hormone receptors or ion channels known to be involved in the cardiovascular regulation of blood pressure and sodium homeostasis. Because irbesartan does not inhibit ACE, it does not affect the response to bradykinin; whether this has clinical relevance is not known.


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Accupril is in a group of drugs called ACE inhibitors. ACE stands for angiotensin converting enzyme.
Accupril is used to treat high blood pressure (hypertension) and heart failure.
Accupril may also be used for purposes other than those listed in this medication guide.

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Possible side effects of Accupril :

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:

Chest pain; coughing; diarrhea; difficulty breathing; dizziness; headache; lightheadedness; nausea; persistent, dry cough; tiredness; vomiting.
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); chest pain; difficulty swallowing or breathing; fainting; hoarseness; infection (sore throat, fever); irregular or slow heartbeat; shortness of breath; unusual stomach pain; yellowing of the skin or eyes.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include: extreme dizziness; low blood pressure; weakness.
Proper storage of Accupril :

Store Accupril at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Protect from moisture, heat, and light. Do not store in the bathroom. Keep Accupril out of the reach of children and away from pets.
General information:
If you have any questions about Accupril , please talk with your doctor, pharmacist, or other health care provider.
Accupril is to be used only by the patient for whom it is prescribed. Do not share it with other people.
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Product Description

Common uses

Due to the possibly significant negative side effects of Accutane, the drug is normally used as a last resort when other forms of acne treatment including the use of over the counter products or prescription antibiotics have not been successful in treating the acne.

Before using

Accutane is a naturally occurring derivative of vitamin A and is detectable in the bloodstream of all people. Vitamin A in large doses has the same effects as Accutane, both good and bad, but quickly becomes harmful since it builds up in the tissue. (Important: Don't take any vitamin A while on Accutane). Accutane is formed naturally in the body from the Vitamin A present in the bloodstream. This is why large amounts of Vitamin A taken during pregnancy cause the same birth defects that Accutane does. Fortunately, because it is a naturally occurring product, the body is able to quickly remove Accutane from the bloodstream. It is gone from the blood within nine days and has no lasting effect on future pregnancies.
Do not start or stop any medicine without doctor or pharmacist approval. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.

Directions

Follow the directions for using this medicine provided by your doctor. This medicine is usually taken two times a day with a meal, unless your doctor tells you otherwise. Swallow the capsule. Don't suck or chew it. Take it with a full glass of water, milk, or other nonalcoholic liquid. Follow your doctor's instructions carefully.
Depending on your reaction to Accutane, your doctor may need to adjust the dosage upward or downward. If you respond quickly and very well, your doctor may take you off Accutane even before the 15 or 20 weeks are up.
After you finish taking Accutane, there should be at least a 2-month "rest period" during which you are off the drug. This is because your acne may continue to get better even though you are no longer taking the medication. Once the 2 months are up, if your acne is still severe, your doctor may want to give you a second course of Accutane. If you are still growing, your doctor may recommend a longer "rest period."
The recommended dosage range for Accutane is 0.5 to 1 milligram per 2.2 pounds of body weight, divided into 2 doses daily, for 15 to 20 weeks. For very severe cases, the doctor may increase the daily dose to as much as 2 milligrams per 2.2 pounds.
If after a period of 2 months or more off therapy, severe cystic acne persists, your doctor may prescribe a second course of therapy


Cautions

Accutane is a potentially dangerous prescription medicine that should only be taken under the close supervision of your healthcare professional and pharmacist. If you are pregnant or may get pregnant, accutane can cause birth defects, miscarriage, premature births, and death in babies.
Avoid consumption of alcoholic beverages.
Read the patient information leaflet available with the product.
Do not crush the capsules.
Do not share Accutane with anyone because of the risk of birth defects and other serious side effects.

Possible side effects

Unfortunately, side effects depend on the dose as well. At the lowest doses, there are almost no side effects at all. At the highest, everyone get rather nasty side effects, which are related on the drying effects on the oil glands. The dose needs to be adjusted to strike a balance between effectiveness and side effects.

Side effects are listed here. Abnormal hair growth or loss, allergic reaction, bleeding gums, blood in urine, bowel inflammation and pain, bruising, changes in blood sugar or cholesterol levels, changes in skin pigmentation, chest pain, decreased night vision, decreased tolerance to contact lenses, delay in wound healing, depression, difficulty sleeping, dizziness, drowsiness, dry or fragile skin, dry or cracked lips, dry mouth, dry nose, fatigue, flushing, headache, hearing problems, heartbeat irregularities, herpes, inflammation or sores in the esophagus, itching, joint pain, liver disorders, menstrual changes, muscle wasting, nail disorders, nausea, nervousness, nosebleeds, peeling palms or soles, pinkeye, rash, skin infections, stomach and intestinal discomfort, stroke, sudden drop in blood pressure (causing unconsciousness), sunburn-sensitive skin, suppression of growth, sweating, swelling due to fluid retention, tendon and ligament problems, urinary discomfort, vision problems, vomiting, weakness, weight loss

Accutane may increase the level of blood fats, sometimes to risky levels. This reverts back to normal when the drug is stopped. Occasionally it may affect the liver. That's why regular blood tests are necessary during Accutane treatment. There is little risk of any damage if these precautions are followed.

The most damaging side effect of Accutane is serious birth defects if taken during pregnancy. It is critically important for women not to take Accutane while pregnant, and not to become pregnant while taking it. Women who are, or might be, sexually active while taking Accutane must use an effective method of birth control, of which the birth control pill is the most effective. Birth control pills do rarely fail, so an additional method of birth control such as a condom for the male partner or a spermicidal foam or sponge is also needed. Because the birth defects caused by Accutane are so serious, it's important not to share the pills with others.

If you take too much

Any medication taken in excess can have serious consequences. If you suspect an overdose of Accutane, seek medical attention immediately.
• Overdosage of Accutane, like overdosage of vitamin A, can cause:
Abdominal pain, dizziness, dry or cracked lips, facial flushing, incoordination and clumsiness, headache, vomiting

Additional information

While taking Accutane, do not take vitamin supplements containing vitamin A. Accutane and vitamin A are chemically related; taking them together is like taking an overdose of vitamin A.
Remember, too, that Accutane should not be combined with tetracycline antibiotics such as Doryx, Minocin, and Vibramycin.

Drug interactions

The concurrent use of Accutane with tetracycline antibiotics or vitamin A supplementation is not recommended. Concurrent use of isotretinoin with tetracyclines significantly increases the risk of idiopathic intracranial hypertension. Concurrent intake of Vitamin A supplementation increases the risk of vitamin A toxicity.
Concurrent use of isotretinoin with methotrexate increases the risk of hepatotoxicity and may increase methotrexate levels. The combination is used with caution and close monitoring of adverse effects and liver function tests.

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