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Acne Drugs: Drug Products & Information
These are just a few of the most common acne medications prescribed by dermatologists and doctors. While this information is accurate, please do not use it as your sole reference. Information may have changed.
Accutane (isotretinoin)
I. Definition:
Isotretinoin (trade name: Accutane) is a powerful drug used in the treatment of acne. Four to five months of isotretinoin treatment usually leads to clearing of acne for one year or more after the medicine is stopped. Most other acne-controlling medicines are antibacterial agents, which are effective only if the medicine is used daily.
II. Side Effects:
Isotretinoin has significant side effects:
(percentages are the ratio of people who received the side-effect)
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Chapped lips 90%
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Dry skin and itching 80% - the use of daily alpha hydroxacids will help prevent this side effect.
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Dryness of nose, mild nosebleed 80%
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Irritation of the eyelids and eyes 40% - Vitamin E 400 IU each day may lessen this side effect.
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Joint and muscle pains 15%
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Temporary hair thinning 10%
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Rash 7%
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Intestinal symptoms 5%
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Urinary symptoms 5%
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Headache 5%
Increased sensitivity to sunburn 5%
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Decreased night vision <1%
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Depression, thoughts of suicide <1%
Isotretinoin may increase the level of blood fats, sometimes to risky levels. Occasionally it may affect the liver. That's why regular blood tests are necessary when you are taking isotretinoin; these tests must be done when you have fasted for 12 hours (no breakfast), so that the blood fat determinations are reliable. A baseline blood chemistry test is established before patients start isotretinoin.
The most damaging side effect of isotretinoin is serious birth defects if
taken during pregnancy.
It is critically important for women not to take isotretinoin while pregnant, and not to become pregnant while taking it. Women who are, or expect to be, sexually active while taking isotretinoin must use an effective method of birth control. This usually means oral contraceptive pills and one other additional method of birth control such as a condoms for the male partner. A woman who does get pregnant while on isotretinoin must be prepared to have an abortion and must state this in writing before many physicians will prescribe isotretinoin for her.
Isotretinoin may cause birth defects as long as two months after it is stopped. After that time, it's safe to become pregnant. Because the birth defects caused by isotretinoin are so serious, it's important not to share the pills with others.
We don't know whether isotretinoin taken by men can cause birth defects, so it's best not to get a woman pregnant while taking isotretinoin. If she is not using birth control, the man should use a condom.
There are a few reports of patients having decreased night vision after using Accutane. One patient still had problems six months after the drug was stopped. If you experience trouble with your vision while on Accutane, call the office right away.
Some people develop headaches while on Accutane. If you develop a persistent headache while on Accutane, call your physician right away. A persistent headache, which will not go away while on Accutane, can be dangerous and you should stop the medication.
Accutane rarely causes depression and thoughts of suicide. If this were to occur stop the medicine immediately and call your physician.
III. How does isotretinoin work?
Isotretinoin decreases the amount of oil produced by the skin's sebaceous (oil) glands. It may be as long as two months before you see improvement in your skin. There's no medicine we can add to speed up isotretinoin's action. In fact, sometimes acne gets worse during the first month or so of treatment. Side effects, such as lip dryness, begin before the acne starts to clear.
IV. How To Use Isotretinoin:
Take the medicine with food, you can take the entire daily dose with supper, this increases the absorption of the medicine.
V. Long-term Results:
Isotretinoin isn't a permanent cure for acne, although it often buys time until nature clears your skin. Your skin may stay clear for months, even years, after isotretinoin is stopped. In about one person in 10, acne comes back after one year. About one person in four has acne again after two years. If your acne returns, antibiotics may work, or you may be treated with isotretinoin again. The use of daily alpha hydroxyacids will help prevent small flare-ups after a course of Accutane.
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Actisite
INDICATIONS AND USAGE:
Actisite (tetracycline hydrochloride) periodontal fiber is indicated as an adjunct to scaling and root planing for reduction of pocket depth and bleeding on probing in patients with adult periodontitis.
Treatment with Actisite is a component of an intervention program which includes good oral hygiene and scaling and root planing. Effectiveness of repeated fiber applications in a site has not been studied.
The effects of Actisite on bone loss, tooth mobility, or tooth loss from periodontal disease has not been established.
CONTRAINDICATIONS:
Actisite® fiber should not be used in patients who are hypersensitive to any tetracycline.
WARNINGS:
The use of the tetracycline class during tooth development (last half of pregnancy, infancy and childhood to age of 8 years) may cause permanent discoloration of the teeth. Tetracycline drugs should not be used in this age group unless other treatment is not likely to be effective or if alternative therapy is contraindicated.
Tetracyclines as a class are associated with photosensitivity. Treatment should be discontinued at the first sign of cutaneous erythema.
Accumulations of tetracycline associated with renal failure can lead to liver toxicity. These effects have not been studied in the plasma concentration range associated with Actisite.
PRECAUTIONS:
General: Actisite fibers must be removed after 10 days. Packing fibers tightly into a draining abscess without allowance for drainage might result in the formation of a lateral fistula. Fibers should not be used in an acutely abscessed periodontal pocket. Their use in chronic abscesses has not been evaluated.
As with other antibiotic preparations, Actisite (tetracycline hydrochloride) periodontal fiber therapy may result in overgrowth of nonsusceptible organisms, including fungi. Actisite should be used with caution in patients with a history of or predisposition to oral candidiasis. The safety and effectiveness of Actisite fiber have not been established for the treatment of periodontitis in patients with coexistent oral candidiasis.
Use of antibiotic preparations may result in the development of resistant bacteria. Resistance has not been observed during 10 days of Actisite fiber therapy. The effects of prolonged treatment have not been studied.
Management of patients with periodontal disease should include a consideration of potentially contributing medical disorders.
Information for Patients: When Actisite fiber is in place, patients should avoid actions that may dislodge the fiber.
Patients should receive the following instructions:
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1.Do not chew hard, crusty, or sticky foods.
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2.Do not brush or floss near any treated areas. (Continue to clean other teeth.)
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3.Do not engage in any other hygienic practices that could potentially dislodge the fibers.
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4.Do not probe at the treated area with tongue or fingers.
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5.Notify the dentist promptly if the fiber is dislodged or falls out before the scheduled recall visit, or if pain or swelling orother problems occur.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Animal studies with Actisite fiber have not been performed to
evaluate carcinogenic potential, mutagenic potential, or effects on fertility.
Pregnancy Category C:
Administration of tetracycline during pregnancy may cause permanent discoloration of teeth of offspring. Animal studies indicate that tetracyclines can cause retardation of fetal skeletal development. Actisite fiber should be administered to a pregnant woman only if clearly needed. Animal reproduction studies have not been conducted with Actisite fiber. It is also not known whether Actisite fiber can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
Nursing Mothers:
Tetracycline appears in breast milk following oral administration. It is not known whether tetracycline is excreted in human milk following use of Actisite® (tetracycline hydrochloride) periodontal fiber. Because of the potential for serious adverse reactions from tetracycline HCl in nursing infants, Actisite fiber should be used in a nursing woman only if clearly needed.
Pediatrics:
The safety and effectiveness of Actisite fiber in children have not been established. Oral doses of tetracycline in children up to 8 years of age have caused permanent discoloration of teeth.
DOSAGE AND ADMINISTRATION:
Actisite (tetracycline hydrochloride) periodontal fiber for 10 days is indicated as an adjunct to scaling and root planing. Repeated fiber applications have not been studied. Actisite fiber should be inserted into the periodontal pocket until the pocket is filled. The length of fiber used will vary with pocket depth and contour. The fiber should be placed to closely approximate the pocket anatomy and should be in contact with the base of the pocket. An appropriate cyanoacrylate adhesive should be used to help secure the fiber in the pocket.
When placed within a periodontal pocket, Actisite fiber provides continuous release of tetracycline for 10 days. At the end of 10 days of treatment, all fibers must be removed. Fibers lost before 7 days should be replaced.
HOW SUPPLIED:
Actisite® (tetracycline hydrochloride) periodontal fiber is available in cartons containing 4 fibers and 10 fibers. Each individually packaged, yellow fiber is 23 cm (9 inches) long and contains 12.7 mg of tetracycline hydrochloride.
NDC 17314-4800-4 (4 Fiber carton)
NDC 17314-4800-1 (10 Fiber carton)
Store at controlled room temperature 15o-30oC (59o-86oF).
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Erythromycin
Uses:
Erythromycin is an antibiotic used to treat a wide variety of bacterial infections, such as respiratory tract infections, middle ear infections, and skin infections.
How To Take This Medication:
This medication is best taken on an empty stomach. It may be taken with food or milk if stomach upset occurs, however, this will reduce blood drug levels. Take each dose with a full glass of water or fluid. The medication must be swallowed whole to prevent stomach upset. Antibiotics work best when the amount of medicine in your body is kept at a constant level. Do this by taking the medication at evenly spaced intervals throughout the day and night. Continue to take this medication until the full prescribed amount is finished even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow resulting in a relapse of the infection.
Side Effects:
May cause stomach upset, diarrhea, loss of appetite, nausea, vomiting and stomach cramps the first few days as your body adjusts to the medication. If these symptoms persist or become severe, inform your doctor.
Precautions:
If you have had liver disease or jaundice (yellowing of the skin or eyes), tell your doctor before you take this drug. Throw away any unused part of your prescription after your doctor tells you to stop taking it. Erythromycin may lose its effectiveness over time and should not be saved to treat other infections. This drug should be used only if clearly needed during pregnancy. Small amounts of drug do appear in breast milk, so consult your doctor before breast-feeding.
Drug Interactions:
Tell your doctor what medications you take, especially carbamazepine, cyclosporine, theophylline, triazolam, warfarin, terfenadine, astemizole or cisapride.
Missed Dose:
If you should miss a dose, take it as soon as remembered unless it is almost time for the next dose. If it is nearly time for the next dose, skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose.
Storage:
Store at room temperature away from moisture and and sunlight. Do not freeze. Do not store in the bathroom.
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Minocycline
Each minocycline hydrochloride capsule, for oral administration, contains the equivalent of 50 mg or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: magnesium stearate and starch (corn).
The 50 mg and 100 mg capsule shells contain: gelatin, silicon dioxide, sodium lauryl sulfate and titanium dioxide.
The 100 mg capsule shell also contains: black iron oxide.
INDICATIONS AND USAGE: Minocycline Hydrochloride Capsules are indicated in the treatment of the following infections:
Skin and skin structure infections caused by Staphylococcus aureus. (Note: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.)
In severe acne, minocycline may be useful adjunctive therapy.
CONTRAINDICATIONS: This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
WARNINGS: MINOCYCLINE, LIKE OTHER TETRACYCLINE-CLASS ANTIBIOTICS, CAN CAUSE FETAL HARM WHEN ADMINISTERED TO A PREGNANT WOMAN. IF ANY TETRACYCLINE IS USED DURING PREGNANCY OR IF THE PATIENT BECOMES PREGNANT WHILE TAKING THESE DRUGS, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE FETUS. THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY, AND CHILDHOOD TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN).
This adverse reaction is more common during long-term use of the drug, but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED DURING TOOTH DEVELOPMENT UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.
All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in young animals (rats and rabbits) given oral tetracycline in doses of 25 mg/kg every six hours. This reaction was shown to be reversible when the drug was discontinued.
Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has been noted in animals treated early in pregnancy.
The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulations of the drug and possible liver toxicity. Under such conditions, lower than usual total doses are indicated, and if therapy is prolonged, serum level determinations of the drug may be advisable.
Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. This has been reported rarely with minocycline.
Central nervous system side effects including lightheadedness, dizziness, or vertigo have been reported with minocycline therapy. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. These symptoms may disappear during therapy and usually disappear rapidly when the drug is discontinued.
PRECAUTIONS: General: As with other antibiotic preparations, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate therapy instituted.
Pseudotumor cerebri (benign intracranial hypertension) in adults has been associated with the use of tetracyclines. The usual clinical manifestations are headache and blurred vision. Bulging fontanels have been associated with the use of tetracyclines in infants. While both of these conditions and related symptoms usually resolve after discontinuation of tetracycline, the possibility for permanent sequelae exists.
Incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy when indicated.
Information for Patients: Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema. This reaction has been reported rarely with use of minocycline.
Patients who experience central nervous system symptoms (see WARNINGS) should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy.
Concurrent use of tetracycline may render oral contraceptives less effective (see Drug Interactions).
Laboratory Tests: In venereal disease when coexistent syphilis is suspected, a dark-field examination should be done before treatment is started and the blood serology repeated monthly for at least four months.
In long-term therapy, periodic laboratory evaluations of organ systems, including hematopoietic, renal, and hepatic studies should be performed.
Drug Interactions: Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.
Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.
Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium, and iron-containing preparations. The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.
Concurrent use of tetracyclines may render oral contraceptives less effective.
Drug/Laboratory Test Interactions: False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Dietary administration of minocycline in long-term tumorigenicity studies in rats resulted in evidence of thyroid tumor production. Minocycline has also been found to produce thyroid hyperplasia in rats and dogs. In addition, there has been evidence of oncogenic activity in rats in studies with a related antibiotic, oxytetracycline (i.e., adrenal and pituitary tumors). Likewise, although mutagenicity studies of minocycline have not been conducted, positive results in in vitro mammalian cell assays (i.e., mouse lymphoma and Chinese hamster lung cells) have been reported for related antibiotics (tetracycline hydrochloride and oxytetracycline). Segment I (fertility and general reproduction) studies have provided evidence that minocycline impairs fertility in male rats.
Teratogenic Effects: Pregnancy: Pregnancy Category D
(See WARNINGS.)
Labor and Delivery: The effect of tetracyclines on labor and delivery is unknown.
Nursing Mothers: Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from the tetracyclines, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother (see WARNINGS).
Pediatric Use: (See WARNINGS.)
ADVERSE REACTIONS: Due to oral minocycline's virtually complete absorption, side effects to the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines.
Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, pancreatitis and inflammatory lesions (with monilial overgrowth) in the anogenital region, increases in liver enzymes. Rarely, hepatitis and liver failure have been reported. Rare instances of esophagitis and esophageal ulcerations have been reported in patients taking the tetracycline-class antibiotics in capsule and tablet form. Most of these patients took the medication immediately before going to bed (see DOSAGE AND ADMINISTRATION).
Skin: Maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Fixed drug eruptions, including balanitis, have been rarely reported. Erythema multiforme and rarely Stevens-Johnson syndrome have been reported. Photosensitivity is discussed above (see WARNINGS). Pigmentation of the skin and mucous membranes has been reported.
Renal toxicity: Elevations in BUN have been reported and are apparently dose related (see WARNINGS).
Hypersensitivity reactions: Urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, pericarditis, exacerbation of systemic lupus erythematosus and rarely pulmonary infiltrates with eosinophilia have been reported. A transient lupus-like syndrome has also been reported.
Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.
Central nervous system: Bulging fontanels in infants and benign intracranial hypertension (Pseudotumor cerebri) in adults (see PRECAUTIONS-General) have been reported. Headache has also been reported.
Other: When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of the thyroid glands. Very rare cases of abnormal thyroid function have been reported.
Decreased hearing has been rarely reported in patients on minocycline hydrochloride.
Tooth discoloration in children less than 8 years of age (see WARNINGS) and also, rarely, in adults have been reported.
OVERDOSAGE: In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures.
DOSAGE AND ADMINISTRATION: THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF MINOCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS.
Minocycline hydrochloride capsules may be taken with or without food. (See CLINICAL PHARMACOLOGY.)
Adults: The usual dosage of minocycline hydrochloride is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg capsules may be given initially followed by one 50 mg capsule four times daily.
For children above 8 years of age: The usual dosage of minocycline hydrochloride is 4 mg/kg initially followed by 2 mg/kg every 12 hours.
Ingestion of adequate amounts of fluids along with capsule forms of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration. In patients with renal impairment (see WARNINGS), the total dosage should be decreased by either reducing the recommended individual doses and/or extending the time intervals between doses.
HOW SUPPLIED: DYNACIN® (MINOCYCLINE HCl CAPSULES, USP) equivalent to 50 mg minocycline are opaque white capsules imprinted "0497" and "DYNACIN 50 mg" supplied in bottles of 100 and 500.
DYNACIN® (MINOCYCLINE HCl CAPSULES, USP) equivalent to 100 mg minocycline are opaque dark gray and opaque white capsules imprinted "0498" and "DYNACIN 100 mg" supplied in bottles of 50 and 500.
Dispense in tight, light-resistant container with child-resistant closure.
Store at controlled room temperature 15-30C (59-86F).
Protect from light, moisture and excessive heat.
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Ortho Tri-Cyclen
ORTHO TRI-CYCLEN® (norgestimate/ethinyl estradiol) is indicated for the prevention of
pregnancy in women who elect to use oral contraceptives as a method of contraception. In addition, it is the only oral contraceptive indicated in the United States for the treatment of moderate acne vulgaris in women 15 years of age or older, who have no known contraindication to oral contraceptive therapy, who desire contraception, who have begun menstruation and who are unresponsive to topical anti-acne medications. It is the first low-dose birth control pill with a noncontraceptive indication since the Pill was introduced over 35 years ago.
Research has demonstrated that ORTHO TRI-CYCLEN decreases the level of a hormone which contributes to the development of acne-producing agents, thus attacking the cause of the acne. In the clinical studies, ORTHO TRI-CYCLEN showed improvement of acne similar to that seen in studies looking at efficacy of benzoyl peroxide and topical or systemic antibiotics.
ORTHO TRI-CYCLEN treats acne with a combination of ethinyl estradiol, a synthetic estrogen, and norgestimate, a progestin. Two randomized, double-blind, placebo-controlled studies demonstrated that improvement of acne was reported during use of ORTHO TRI-CYCLEN in more than 80 percent of the studies' participants treated with ORTHO TRI-CYCLEN.
Serious as well as minor side effects have been reported with the use of oral contraceptives. Serious risks, which can be life threatening, include blood clots, stroke and heart attacks are increased if you smoke cigarettes. Some studies have reported an increase in the risk of developing breast cancer among women who use oral contraceptives. However, the majority of studies have found no overall increase in this risk. Some studies have reported an increase of developing breast cancer, particularly at a younger age. This increased relative risk appears to be related to duration of use. You should speak to your healthcare professional about how this risk relates to your use of the pill.
ORTHO TRI-CYCLEN, like all oral contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.
For information on Warnings, Precautions, and additional Adverse Reactions that may occur, regardless of drug relationship please see product package insert for full U.S. prescribing information.
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Retin-A
There are three different forms of RETIN-A -- cream, gel and liquid. They are available in different strengths that are available from your health care professional. Unlike many over-the-counter acne treatments, RETIN-A has the ability to get beneath the surface of your skin and work where acne begins. While the exact mechanism of action is unknown, RETIN-A is thought to loosen and expel existing acne plugs in the skin and prevent new lesions from forming. It directly attacks the cause of acne, the plug.
RETIN-A should be applied to the face once a day, before bed, using enough to cover the entire face lightly. Patients should wait 20-30 minutes after washing before applying RETIN-A.
Therapeutic results should be noticed after two to three weeks, but more than six weeks of therapy may be required before beneficial effects are seen. During the first few weeks of therapy, an exacerbation of pimples may occur. This is due to the action of the medication on deep, previously unseen pimples and should not be considered a reason to discontinue use. During the first few weeks of therapy, some irritation, including redness and peeling, will be experienced by most patients. Generally, these effects are manageable and diminish over time. However, some people with sensitive skin may experience excessive irritation. The manufacturer recommends application of RETIN-A once daily in the evening after washing (see above). This product must also be used with caution in the sunlight, as it thins the stratum corneum (outermost layer of the skin), making the skin sensitive to sunlight.
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