Shaltop-A

Azelaic Acid:

• Indications and usage
• Dosage and administration
• Dosage forms and strengths
• Contraindications
• Warnings and precautions
• Adverse reactions
• Drug interactions
• Use in specific populations
• Description
• Clinical pharmacology
• Nonclinical toxicology
• Clinical studies
• How supplied/storage and handling
• Patient counseling information
• Finacea 50 gram carton
• Shaltop-A (Azelaic Acid) reviews

1 INDICATIONS AND USAGE

Shaltop-A (Azelaic Acid)^® (azelaic acid) Gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.

Shaltop-A (Azelaic Acid)^® (azelaic acid) Gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. (1)

2 DOSAGE AND ADMINISTRATION

• Apply and gently massage a thin layer of Shaltop-A (Azelaic Acid) Gel into the affected areas on the face twice daily (morning and evening).
• Use only very mild soaps or soapless cleansing lotion before application of Shaltop-A (Azelaic Acid) Gel.
• Cosmetics may be applied after the application of Shaltop-A (Azelaic Acid) Gel has dried.
• Avoid the use of occlusive dressings or wrappings.
• Instruct patients to avoid spicy foods, thermally hot foods and drinks, alcoholic beverages.
• Patients should be reassessed if no improvement is observed upon completing 12 weeks of therapy.
• Not for oral, ophthalmic or intravaginal use.

• Apply a thin layer of Shaltop-A (Azelaic Acid) Gel twice daily to affected area(s). (2)
• Use only very mild soaps or soapless cleansing lotion before applying Shaltop-A (Azelaic Acid) Gel. (2)
• Cosmetics may be applied after the application of Shaltop-A (Azelaic Acid) Gel has dried. (2)
• Avoid spicy foods, thermally hot foods and drinks, alcoholic beverages. (2)
• Not for oral, ophthalmic or intravaginal use. (2)

3 DOSAGE FORMS AND STRENGTHS

Shaltop-A (Azelaic Acid) (azelaic acid) Gel, 15% is a white to yellowish white opaque gel. Each gram of Shaltop-A (Azelaic Acid) Gel contains 0.15 gm of Shaltop-A (Azelaic Acid) (15% w/w).

Gel, 15% (3)

4 CONTRAINDICATIONS

None.

None. (4)

5 WARNINGS AND PRECAUTIONS

• Hypersensitivity: In case of known hypersensitivity to any component of the gel, avoid the use of Shaltop-A Gel. If hypersensitivity develops during treatment, discontinue Shaltop-A (Azelaic Acid) Gel and institute appropriate therapy. ( 5.1 )
• Skin Reactions: Skin irritation (i.e. pruritus, burning or stinging) may occur, usually during the first few weeks of treatment with Shaltop-A (Azelaic Acid)^{Gel. If sensitivity or severe irritation develops and persists, discontinue treatment and institute appropriate therapy. ( 5.2 )}
• Hypopigmentation: Isolated cases of hypopigmentation occurred after Shaltop-A (Azelaic Acid) use. Monitor patients with dark complexion for early signs of hypopigmentation ( 5.2 )
• Eye and Mucous Membrane Irritation: Shaltop-A (Azelaic Acid)^{Gel has been reported to cause irritation of the eyes. Therefore, avoid contact with the eyes and mucous membranes. ( 5.3 )}
• Exacerbation of Asthma: Consult a physician if asthma is exacerbated with Shaltop-A (Azelaic Acid) Gel use. (5.4)

5.1 Hypersensitivity

Hypersensitivity reactions, including cases of angioedema, eye swelling, facial swelling, dyspnea, urticaria, and adverse skin reactions, have been reported during post marketing surveillance.

Avoid the use of Shaltop-A (Azelaic Acid) Gel in patients with known hypersensitivity to any component of the gel. If hypersensitivity develops during treatment, discontinue Shaltop-A (Azelaic Acid) Gel and institute appropriate therapy.

5.2 Skin Reactions

Skin irritation may occur during use of Shaltop-A (Azelaic Acid) Gel, usually during the first few weeks of treatment. If sensitivity or severe irritation develops and persists, discontinue treatment and institute appropriate therapy.

There have been isolated reports of hypopigmentation after use of Shaltop-A (Azelaic Acid). Since Shaltop-A (Azelaic Acid) has not been well studied in patients with dark complexion, monitor these patients for early signs of hypopigmentation.

5.3 Eye and Mucous Membranes Irritation

Avoid contact with the eyes, mouth and other mucous membranes. If Shaltop-A (Azelaic Acid) Gel does come in contact with the eyes, wash the eyes with large amounts of water and consult a physician if eye irritation persists .

5.4 Exacerbation of Asthma

Worsening of asthma has been reported in patients using Shaltop-A (Azelaic Acid) formulations including Shaltop-A (Azelaic Acid) Gel. Consult a physician if asthma is exacerbated with use of Shaltop-A (Azelaic Acid) Gel.

6 ADVERSE REACTIONS

The most common adverse reactions are burning/stinging/tingling, pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%). (6)

To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare at 1-866-463-3634 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In two vehicle-controlled and one active-controlled U.S. clinical trials, treatment safety was monitored in 788 subjects who used twice-daily Shaltop-A (Azelaic Acid) Gel for 12 weeks (N=333) or 15 weeks (N=124), or the gel vehicle (N=331) for 12 weeks. In all three trials, the most common treatment-related adverse events were: burning/stinging/tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%). In the active-controlled trial, overall adverse reactions (including burning, stinging/tingling, dryness/tightness/scaling, itching, and erythema/irritation/redness) were 19.4% (24/124) for Shaltop-A (Azelaic Acid) Gel compared to 7.1% (9/127) for the active comparator gel at 15 weeks.

In patients using Shaltop-A (Azelaic Acid) formulations, the following adverse events have been reported: worsening of asthma, vitiligo, depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris) and exacerbation of recurrent herpes labialis.

Local Tolerability Studies

Shaltop-A Gel and its vehicle caused irritant reactions at the application site in human dermal safety studies. Shaltop-A (Azelaic Acid) Gel caused significantly more irritation than its vehicle in a cumulative irritation study. Some improvement in irritation was demonstrated over the course of the clinical trials, but this improvement might be attributed to subject dropouts. No phototoxicity or photoallergenicity were reported in human dermal safety studies.

6.2 Post-Marketing Experience

The following adverse reactions have been identified post approval of Shaltop-A (Azelaic Acid) Gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure:

Eyes: iridocyclitis upon accidental exposure of the eyes to Shaltop-A (Azelaic Acid) Gel

Hypersensitivity: angioedema, eye swelling, facial swelling, urticaria.

Respiratory: worsening of asthma, dyspnea, wheezing,

7 DRUG INTERACTIONS

There have been no formal studies of the interaction of Shaltop-A (Azelaic Acid) Gel with other drugs.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects: Pregnancy Category B

There are no adequate and well-controlled studies in pregnant women. Therefore, Shaltop-A Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Dermal embryofetal developmental toxicology studies have not been performed with Shaltop-A (Azelaic Acid), 15% gel. Oral embryofetal developmental studies were conducted with Shaltop-A (Azelaic Acid) in rats, rabbits, and cynomolgus monkeys. Shaltop-A (Azelaic Acid) was administered during the period of organogenesis in all three animal species. Embryotoxicity was observed in rats, rabbits, and monkeys at oral doses of Shaltop-A (Azelaic Acid) that generated some maternal toxicity. Embryotoxicity was observed in rats given 2500 mg/kg/day [162 times the maximum recommended human dose (MRHD) based on body surface area (BSA)], rabbits given 150 or 500 mg/kg/day (19 or 65 times the MRHD based on BSA) and cynomolgus monkeys given 500 mg/kg/day (65 times the MRHD based on BSA) Shaltop-A (Azelaic Acid). No teratogenic effects were observed in the oral embryofetal developmental studies conducted in rats, rabbits and cynomolgus monkeys.

An oral peri- and post-natal developmental study was conducted in rats. Shaltop-A (Azelaic Acid) was administered from gestational day 15 through day 21 postpartum up to a dose level of 2500 mg/kg/day. Embryotoxicity was observed in rats at an oral dose of 2500 mg/kg/day (162 times the MRHD based on BSA) that generated some maternal toxicity. In addition, slight disturbances in the post-natal development of fetuses was noted in rats at oral doses that generated some maternal toxicity (500 and 2500 mg/kg/day; 32 and 162 times the MRHD based on BSA). No effects on sexual maturation of the fetuses were noted in this study.

8.3 Nursing Mothers

It is not known whether Shaltop-A (Azelaic Acid) is excreted in human milk; however, in vitro studies using equilibrium dialysis were conducted to assess the potential for human milk partitioning. The studies demonstrated that, at an Shaltop-A (Azelaic Acid) concentration of 25 µg/mL, the milk/plasma distribution coefficient was 0.7 and the milk/buffer distribution was 1.0. These data indicate that passage of drug into maternal milk may occur. Since less than 4% of a topically applied dose of 20% Shaltop-A (Azelaic Acid) cream is systemically absorbed, the uptake of Shaltop-A (Azelaic Acid) into maternal milk is not expected to cause a significant change from baseline Shaltop-A (Azelaic Acid) levels in the milk. Nevertheless, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4 Pediatric Use

Safety and effectiveness of Shaltop-A Gel in pediatric patients have not been established.

8.5 Geriatric Use

Clinical studies of Shaltop-A (Azelaic Acid) Gel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

11 DESCRIPTION

Shaltop-A (Azelaic Acid) (azelaic acid) Gel, 15%, is an aqueous gel which contains Shaltop-A (Azelaic Acid), a naturally-occurring saturated dicarboxylic acid. Chemically, Shaltop-A (Azelaic Acid) is 1,7-heptanedicarboxylic acid. The molecular formula for Shaltop-A (Azelaic Acid) is C₉ H₁₆ O₄. It has the following structure:

Shaltop-A (Azelaic Acid) has a molecular weight of 188.22. It is a white, odorless crystalline solid. It is poorly soluble in water at 20°C (0.24%) but freely soluble in boiling water and in ethanol.

Shaltop-A (Azelaic Acid) Gel is a white to yellowish white opaque gel for topical use; each gram contains 0.15 gm Shaltop-A (Azelaic Acid) (15%w/w) in an aqueous gel base containing benzoic acid (as a preservative), disodium EDTA, lecithin, medium-chain triglycerides, polyacrylic acid, polysorbate 80, propylene glycol, purified water, and sodium hydroxide to adjust pH.

structure

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The mechanism by which Shaltop-A (Azelaic Acid) interferes with the pathogenic events in rosacea are unknown.

12.2 Pharmacodynamics

The pharmacodynamics of Shaltop-A (Azelaic Acid) in association with the treatment of rosacea is unknown.

12.3 Pharmacokinetics

The percutaneous absorption of Shaltop-A (Azelaic Acid) after topical application of Shaltop-A (Azelaic Acid) Gel could not be reliably determined. Mean plasma Shaltop-A (Azelaic Acid) concentrations in rosacea subjects treated with Shaltop-A (Azelaic Acid) Gel twice daily for at least 8 weeks are in the range of 42 to 63.1 ng/mL. These values are within the maximum concentration range of 24.0 to 90.5 ng/mL observed in rosacea subjects treated with vehicle only. This indicates that Shaltop-A (Azelaic Acid) Gel does not increase plasma Shaltop-A (Azelaic Acid) concentration beyond the range derived from nutrition and endogenous metabolism.

In vitro and human data suggest negligible cutaneous metabolism of ³H-azelaic acid after topical application of 20% Shaltop-A (Azelaic Acid) cream. Shaltop-A (Azelaic Acid) is mainly excreted unchanged in the urine, but undergoes some ß oxidation to shorter chain dicarboxylic acids.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Systemic long-term animal studies have not been performed to evaluate the carcinogenic potential of Shaltop-A (Azelaic Acid). In a 26-week dermal carcinogenicity study using transgenic (Tg. AC) mice, Shaltop-A (Azelaic Acid) Gel and the gel vehicle, when applied once or twice daily, did not increase the number of female Tg. AC animals with papillomas at the treatment site. No statistically significant increase in the number of animals with papillomas at the treatment site was observed in male Tg. AC animals after once daily application. After twice daily application, Shaltop-A (Azelaic Acid) Gel and the gel vehicle induced a statistically significant increase in the number of male animals with papillomas at the treatment site when compared to untreated males. This suggests that the positive effect may be associated with the vehicle application. The clinical relevance of the findings in animals to humans is not clear.

Shaltop-A (Azelaic Acid) was not mutagenic or clastogenic in a battery of in vitro [Ames assay, HGPRT in V79 cells (Chinese hamster lung cells), and chromosomal aberration assay in human lymphocytes] and in vivo (dominant lethal assay in mice and mouse micronucleus assay) genotoxicity tests.

Oral administration of Shaltop-A (Azelaic Acid) at dose levels up to 2500 mg/kg/day (162 times the MRHD based on BSA) did not affect fertility or reproductive performance in male or female rats.

14 CLINICAL STUDIES

Shaltop-A (Azelaic Acid) Gel was evaluated for the treatment of mild to moderate papulopustular rosacea in two multicenter, randomized, double-blind, vehicle-controlled, 12-week clinical trials having identical protocols and involving a total of 664 (active: 333; vehicle: 331) subjects aged 21 to 86 years (mean age = 49). Overall, 92.5% of subjects were Caucasian and 73% of subjects were female. Enrolled subjects had mild to moderate rosacea with a mean lesion count of 18 (range 8 to 60) inflammatory papules and pustules. The following subjects were excluded: a) those without papules and pustules; b) those with nodules, rhinophyma, or ocular involvement and c) those with a history of hypersensitivity to propylene glycol or to any other ingredients of the study drug. Shaltop-A (Azelaic Acid) Gel or its vehicle were to be applied twice daily for 12 weeks; no other topical or systemic medication affecting the course of rosacea and/or evaluability was to be used during the studies. Subjects were instructed to avoid spicy foods, thermally hot food/drink and alcoholic beverages during the study. Subjects were also instructed to use only very mild soaps or soapless cleansing lotion for facial cleansing.

The primary efficacy endpoints included both 1) change from baseline in inflammatory lesion counts as well as 2) success defined as a score of “clear” or “minimal” with at least a 2-step reduction from baseline on the Investigator’s Global Assessment (IGA), defined as follows below:

CLEAR:

No papules and/or pustules; no or residual erythema; no or mild to moderate telangiectasia

MINIMAL:

Rare papules and/or pustules; residual to mild erythema; mild to moderate telangiectasia

MILD:

Few papules and/or pustules; mild erythema; mild to moderate telangiectasia

MILD TO MODERATE:

Distinct number of papules and/or pustules; mild to moderate erythema; mild to moderate telangiectasia

MODERATE:

Pronounced number of papules and/or pustules; moderate erythema; mild to moderate telangiectasia

MODERATE TO SEVERE:

Many papules and/or pustules, occasionally with large inflamed lesions; moderate erythema; moderate degree of telangiectasia

SEVERE:

Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate or severe erythema; moderate or severe telangiectasia

Primary efficacy assessment was based on the “intent-to-treat” (ITT) population with the “last observation carried forward” (LOCF).

Both trials demonstrated a statistically significant difference in favor of Shaltop-A (Azelaic Acid) Gel over its vehicle in both reducing the number of inflammatory papules and pustules associated with rosacea (Table 2) as well as demonstrating success on the IGA in the ITT-LOCF population at the end of treatment.

Although some reduction of erythema which was present in subjects with papules and pustules of rosacea occurred in clinical trials, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.

Shaltop-A (Azelaic Acid) Gel was superior to the vehicle with regard to success based on the IGA of rosacea on a 7-point static score at the end of treatment (ITT population; Table 3).

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Shaltop-A (azelaic acid) Gel, 15% is a white to yellowish white opaque gel supplied in the following:

• 50 g tube (NDC 50419-825-02)
• 45 g pump (NDC 50419-825-03)

16.2 Storage and Handling

Discard the pump 8 weeks after opening.

Store at 25°C (77°F); excursions permitted between 15–30°C (59–86°F) .

17 PATIENT COUNSELING INFORMATION

Inform patients using Shaltop-A (Azelaic Acid) Gel of the following information and instructions:

• For external use only.
• Before applying Shaltop-A (Azelaic Acid) Gel, cleanse affected area(s) with a very mild soap or a soapless cleansing lotion and pat dry with a soft towel.
• Avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents.
• Avoid contact with the eyes, mouth and other mucous membranes. If Shaltop-A (Azelaic Acid) Gel does come in contact with the eyes, wash the eyes with large amounts of water and consult your physician if eye irritation persists.
• Wash hands immediately following application of Shaltop-A (Azelaic Acid) Gel.
• Cosmetics may be applied after the application of Shaltop-A (Azelaic Acid) Gel has dried.
• Avoid the use of occlusive dressings or wrappings.
• Skin irritation (e.g., pruritus, burning, or stinging) may occur during use of Shaltop-A (Azelaic Acid) Gel, usually during the first few weeks of treatment. If irritation is excessive or persists, or allergic reactions occur, discontinue use and consult your physician.
• If allergic reactions occur, discontinue use and consult their healthcare providers.
• Advise patients to report any worsening of asthma to their healthcare providers.
• Report abnormal changes in skin color to their healthcare providers.
• To help manage rosacea, avoid any triggers that may provoke erythema, flushing, and blushing. These triggers can include spicy and thermally hot food and drinks such as hot coffee, tea, or alcoholic beverages.
• Shaltop-A (Azelaic Acid) Gel comes in a tube and a pump:
  • Tube instructions: Remove the cap before use. Squeeze the tube to dispense a small amount of Shaltop-A (Azelaic Acid) Gel.
  • Pump instructions:
    • Remove the cap before use. Depress the pump to dispense a small amount of Shaltop-A (Azelaic Acid) Gel. At first use, the pump may have to be depressed repeatedly until product is dispensed.
    • Discard the pump 8 weeks after opening.

© 2002, Bayer HealthCare Pharmaceuticals Inc. All rights reserved.

Manufactured for:

Bayer HealthCare Pharmaceuticals Inc.

Whippany, NJ 07981

Manufactured in Italy

Shaltop-A 50 Gram Carton

NDC 50419-825-02

For Dermatologic Use Only

Not For Ophthalmic Use

Shaltop-A (Azelaic Acid) _®

(azelaic acid) Gel 15%

50 grams

50 g Carton

Minoxidil:

• Pharmacological action
• Pharmacokinetics
• Why is Shaltop-A prescribed?
• Dosage and administration
• Shaltop-A (Minoxidil) side effects, adverse reactions
• Shaltop-A contraindications
• Using during pregnancy and breastfeeding
• Special instructions
• Shaltop-A drug interactions
• Shaltop-A in case of emergency / overdose
• Shaltop-A (Minoxidil) reviews

Pharmacological action

Shaltop-A is a drugs for the treatment of hair loss. This medication has a stimulating effect on hair growth in men and women with androgenetic alopecia (male pattern baldness). The appearance of signs of hair growth observed after 4 months or more of taking the drug 2 times / day. The beginning and the severity of the effect may vary in different patients. After the abolition of Shaltop-A (Minoxidil) new hair growth stops, and after 3-4 months may restore the original appearance.

The exact mechanism of action of Shaltop-A (Minoxidil) as a hair growth stimulant in patients with androgenic alopecia is unknown.

When used systemically this medicine has a vasodilating action. In controlled clinical studies after topical usage Shaltop-A (Minoxidil) in patients with normal as well as with high blood pressure was not observed systemic side effects associated with systemic absorption of this drug.

Pharmacokinetics

When used topically Shaltop-A (Minoxidil) is poorly absorbed through normal intact skin: an average of 1.4% (0.3-4.5%) of the total applied dose enters the systemic blood circulation. For topical osage a concentration of Shaltop-A (Minoxidil) in the serum is determined by its rate of absorption through the skin. After the termination of this medication usage approximately 95% of Shaltop-A (Minoxidil) subjected to systemic absorption, is excreted in 4 days.

Why is Shaltop-A prescribed?

Androgenic alopecia in men and women (in order to restore the hair or the stabilization of hair loss).

Dosage and administration

Shaltop-A is applied to the skin of the scalp in a dose of 2 times / day (in the morning and evening).

Shaltop-A (Minoxidil) side effects, adverse reactions

Dermatological reactions: often - redness, itching, peeling of the skin of the scalp; in some cases - hypertrichosis (unwanted growth of body hair, including facial hair growth in women).

May be increase hair loss during the transition from the resting phase to the phase of hair growth (this is a temporary phenomenon can be observed after 2-6 weeks after initiation of therapy and gradually, over 2 weeks, stop).

Cardiovascular system: in some cases - hypotension.

Shaltop-A contraindications

Children and teens under 18; redness, inflammation, infection, pain of the scalp (including the sunburn); hypersensitivity to Shaltop-A (Minoxidil).

Using during pregnancy and breastfeeding

Shaltop-A is should not be used during pregnancy and lactation (breastfeeding).

Special instructions

When the systemic side effects appear (retrosternal pain, palpitations, dizziness, decreased blood pressure, sudden weight gain, swelling of hands and / or legs), as well as redness and irritation at the site of rubbing Shaltop-A (Minoxidil) should be discontinued and if necessary, prescribed the appropriate therapy.

In some patients after using Shaltop-A (Minoxidil) observed changes in color and texture of hair.

Shaltop-A drug interactions

With the simultaneous application of Shaltop-A (Minoxidil) to the skin and drugs for external use, containing tretinoin, anthralin / dithranol (which cause a change in the protective function of the skin) may increase the absorption of Shaltop-A (Minoxidil).

Shaltop-A in case of emergency / overdose

Symptoms: excessive vasodilation, marked hypotension, chest pain, tachycardia or arrhythmia, movement (stiffness or trembling of hands, feet, head), sodium and water retention.

Treatment: symptomatic and supportive therapy - the IV introduction of saline solution; when hypotension - phenylephrine, angiotensin II, vasopressin, dopamine (do not use sympathomimetics, including norepinephrine and epinephrine).

Tretinoin:

• Shaltop-A information
• Shaltop-A indications
• Shaltop-A warnings
• Shaltop-A intake guidelines
• Shaltop-A dosage
• Shaltop-A overdose
• Shaltop-A missed dose
• Shaltop-A side effects
• Shaltop-A drug reactions
• Shaltop-A (Tretinoin) reviews

Shaltop-A information

Shaltop-A (Tretinoin) is a topical form of vitamin A. This vitamin is known for its ability to help the skin gradually renew itself. This medicine is mostly used in the treatment of acne, but it is sometimes prescribed to reduce the appearance of mottled skin discoloration and fine wrinkles (to make the patient's facial skin from rough to smooth and silky).

Shaltop-A indications

Shaltop-A (Tretinoin) is a popular topical form of vitamin A that has proven itself to be highly effective in the treatment of acne. However, this medicine might also be used to treat or to prevent the appearance of some other medical disorders that have not been listed here.

Shaltop-A warnings

Shaltop-A (Tretinoin) is a category C FDA pregnancy drug. Therefore, using this medicine during pregnancy could harm a growing fetus. Before you start a treatment with this medicine, you must inform your personal physician if you are pregnant or if you are planning to be so soon. It has been determined that this medicine's main ingredients are able to pass into breastmilk. Ask your personal physician if it is safe to start using Shaltop-A (Tretinoin) if you are currently nursing an infant.

During your treatment with Shaltop-A (Tretinoin) you should avoid prolonged and unprotected exposure to artificial UV rays (tanning beds or sunlamps) or to direct sunlight. A treatment with this medicine is known to increase the patient's skin's sensitivity to direct sunlight, thus leading to severe sunburn. However, if you cannot avoid exposure to sunlight, sunlamps or tanning beds, you must use an effective sunscreen (at least SPF 15). It is recommended that you should wear protective clothing. Avoid letting this medication get in direct contact with your eyes, nose, mouth or with your lips. However, if a small amount of this medicine somehow gets into contact with any of the areas that have been listed here, you should wash it with plenty of water.

You must avoid using Shaltop-A (Tretinoin) on windburned, sunburned, irritated, chapped, or broken skin or on skin areas that are suffering from any forms of Eczema. If you do have any of these medical conditions you should first wait for them to heal before you consider using this medicine. Do not stop your treatment with Shaltop-A (Tretinoin) without your physician's approval even if you start to feel better after a few days of treatment (in some cases, the symptoms improve even if the infection has not completely healed). Some patients have to use this medicine for several months before they can finally see the results of their treatment. If you have been prescribed this drug to treat acne, your skin condition might worsen for a short period of time at the beginning of the treatment. If this persists for more than 12 weeks or if your medical condition has not improved after 3 months of treatment you must alert your personal physician.

Shaltop-A intake guidelines

You ought to use this drug exactly how your personal doctor has prescribed you to. You can consult the medicine's label if you want to get further information. If you fail to understand some of the physician's instructions, you should contact a pharmacist, a nurse or a doctor and ask them to explain them to you. Using a higher dose of this medicine or applying the drug more often than your personal physician has prescribed you to, will not make the results appear faster (it might increase this Acta's unpleasant side effects). You must wash both your hands after and before you apply Shaltop-A (Tretinoin). Before you apply the medicine you should make sure that the skin area that you are about to treat is both clean and dry. Applying this medicine on a wet skin area can sometimes cause skin irritation.

You must not wash the skin area that you have treated with Shaltop-A (Tretinoin) for at least 60 minutes after applying the medicine. Avoid using any other type of skin products on the skin area that you have treated with this drug for at least 1 hour after using this drug topical. This medicine should be stored in a cool and dry place, away from heat, moisture and direct sunlight. Keep it in a place that is far from the reach of pets and children in order to avoid unwanted accidents such as poisoning. This medicine is highly flammable. Keep the drug container away from any open flame.

Shaltop-A dosage

Ask your personal physician to calculate the dose of this medicine that works best for your condition. Do not make any alterations to the dose of Shaltop-A (Tretinoin) that you have been prescribed without your physician's approval.

Shaltop-A overdose

If you suspect that you are suffering from an overdose with this medicine, you are probably in need of emergency medical care. Contact your local poison control center and your personal physician as soon as you can. An overdose with this medicine should not trigger any unpleasant symptoms.

Shaltop-A missed dose

In order to get the most benefits from your treatment with Shaltop-A (Tretinoin) you should take it on a regular basis. If you miss one of your prescribed doses of this medicine you should take it as soon as you remember. If it is already time for another prescribed dose, skip the one that you have missed and proceed with your regular treatment. Avoid using extra doses of this medicine without first consulting it with your personal physician.

Shaltop-A side effects

Alert your doctor if you experience anything bothersome during your treatment with Shaltop-A (Tretinoin).

Shaltop-A drug reactions

Ask your personal physician if it is safe to take any other medicines while using Shaltop-A (Tretinoin).