Trigaine

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Trigaine uses

Trigaine consists of Alcohol, Azelaic Acid, Minoxidil, Tretinoin.

Alcohol:


Drug Facts

Active Ingredients

​Petrolatum 85%

Dimethicone 1.5%

Purpose

​Skin Protectant

Uses

Temporarily protects minor - cuts - scrapes - burns -- Helps prevent, temporarily protects, and helps relieve chafed, chapped or cracked skin. Helps prevent and protect from the drying effects of wind and cold weather.

Warnings

For external use only.

Do not use on

- deep or puncture wounds - animal bites - serious burns

When using this product

do not get into eyes.

Stop use and ask a doctor if

- condition worsens - symptoms last more than 7 days or clear up and occur again within few days.

Directions:

Apply as needed.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Other Information:

Store in a cool dry place with lid closed tightly

Inactive Ingredients

Diazolidinyl Urea, Methylparaben, Propylene Glycol, Propylparaben, Zinc Stearate

Questions?

(800) 345-2231

SkinLube

Azelaic Acid:


1 INDICATIONS AND USAGE

Trigaine (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.

Trigaine (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 Trigaine (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 Trigaine (Azelaic Acid) Gel.
  • Cosmetics may be applied after the application of Trigaine (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 Trigaine (Azelaic Acid) Gel twice daily to affected area(s). (2)
  • Use only very mild soaps or soapless cleansing lotion before applying Trigaine (Azelaic Acid) Gel. (2)
  • Cosmetics may be applied after the application of Trigaine (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)
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3 DOSAGE FORMS AND STRENGTHS

Trigaine (Azelaic Acid) (azelaic acid) Gel, 15% is a white to yellowish white opaque gel. Each gram of Trigaine (Azelaic Acid) Gel contains 0.15 gm of Trigaine (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 Trigaine Gel. If hypersensitivity develops during treatment, discontinue Trigaine (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 Trigaine (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 Trigaine (Azelaic Acid) use. Monitor patients with dark complexion for early signs of hypopigmentation ( 5.2 )
  • Eye and Mucous Membrane Irritation: Trigaine (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 Trigaine (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 Trigaine (Azelaic Acid) Gel in patients with known hypersensitivity to any component of the gel. If hypersensitivity develops during treatment, discontinue Trigaine (Azelaic Acid) Gel and institute appropriate therapy.

5.2 Skin Reactions

Skin irritation may occur during use of Trigaine (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 Trigaine (Azelaic Acid). Since Trigaine (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 Trigaine (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 Trigaine (Azelaic Acid) formulations including Trigaine (Azelaic Acid) Gel. Consult a physician if asthma is exacerbated with use of Trigaine (Azelaic Acid) Gel.

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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 Trigaine (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 Trigaine (Azelaic Acid) Gel compared to 7.1% (9/127) for the active comparator gel at 15 weeks.


Trigaine (Azelaic Acid) Gel, 15%

N=457

(100%)


Vehicle

N=331

(100%)


Mild

N=99

(22%)


Moderate

N=61

(13%)


Severe

N=27

(6%)


Mild

N=46

(14%)


Moderate

N=30

(9%)


Severe

N=5

(2%)


Burning/stinging/tingling


71 (16%)


42 (9%)


17 (4%)


8 (2%)


6 (2%)


2 (1%)


Pruritus


29 (6%)


18 (4%)


5 (1%)


9 (3%)


6 (2%)


0 (0%)


Scaling/dry skin/xerosis


21 (5%)


10 (2%)


5 (1%)


31 (9%)


14 (4%)


1 (<1%)


Erythema/irritation


6 (1%)


7 (2%)


2 (<1%)


8 (2%)


4 (1%)


2 (1%)


Contact dermatitis


2 (<1%)


3 (1%)


0 (0%)


1 (<1%)


0 (0%)


0 (0%)


Edema


3 (1%)


2 (<1%)


0 (0%)


3 (1%)


0 (0%)


0 (0%)


Acne


3 (1%)


1 (<1%)


0 (0%)


1 (<1%)


0 (0%)


0 (0%)

  • *Subjects may have >1 cutaneous adverse event; thus, the sum of the frequencies of preferred terms may exceed the number of subjects with at least 1 cutaneous adverse event.

In patients using Trigaine (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

Trigaine Gel and its vehicle caused irritant reactions at the application site in human dermal safety studies. Trigaine (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 Trigaine (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 Trigaine (Azelaic Acid) Gel

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

Respiratory: worsening of asthma, dyspnea, wheezing,

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7 DRUG INTERACTIONS

There have been no formal studies of the interaction of Trigaine (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, Trigaine 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 Trigaine (Azelaic Acid), 15% gel. Oral embryofetal developmental studies were conducted with Trigaine (Azelaic Acid) in rats, rabbits, and cynomolgus monkeys. Trigaine (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 Trigaine (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) Trigaine (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. Trigaine (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 Trigaine (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 Trigaine (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% Trigaine (Azelaic Acid) cream is systemically absorbed, the uptake of Trigaine (Azelaic Acid) into maternal milk is not expected to cause a significant change from baseline Trigaine (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 Trigaine Gel in pediatric patients have not been established.

8.5 Geriatric Use

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

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11 DESCRIPTION

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

Trigaine (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.

Trigaine (Azelaic Acid) Gel is a white to yellowish white opaque gel for topical use; each gram contains 0.15 gm Trigaine (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 Trigaine (Azelaic Acid) interferes with the pathogenic events in rosacea are unknown.

12.2 Pharmacodynamics

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

12.3 Pharmacokinetics

The percutaneous absorption of Trigaine (Azelaic Acid) after topical application of Trigaine (Azelaic Acid) Gel could not be reliably determined. Mean plasma Trigaine (Azelaic Acid) concentrations in rosacea subjects treated with Trigaine (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 Trigaine (Azelaic Acid) Gel does not increase plasma Trigaine (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% Trigaine (Azelaic Acid) cream. Trigaine (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 Trigaine (Azelaic Acid). In a 26-week dermal carcinogenicity study using transgenic (Tg. AC) mice, Trigaine (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, Trigaine (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.

Trigaine (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 Trigaine (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

Trigaine (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. Trigaine (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 Trigaine (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.

*ITT population with last observation carried forward (LOCF)

Study One

Trigaine (Azelaic Acid) Gel, 15%

N=164


Study One

VEHICLE

N=165


Study Two

Trigaine (Azelaic Acid) Gel, 15%

N=167


Study Two

VEHICLE

N=166


Mean Lesion Count

Baseline


17.5


17.6


17.9


18.5


End of Treatment*


6.8


10.5


9.0


12.1


Mean Percent Reduction End of Treatment*


57.9%


39.9%


50.0%


38.2%


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.

Trigaine (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).

*ITT population with last observation carried forward (LOCF)

Study One

Trigaine (Azelaic Acid) Gel, 15%

N=164


Study One

VEHICLE

N=165


Study Two

Trigaine (Azelaic Acid) Gel, 15%

N=167


Study Two

VEHICLE

N=166


Clear, Minimal or Mild at End of Treatment

(% of Subjects)


61%


40%


61%


48%

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Trigaine (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 Trigaine (Azelaic Acid) Gel of the following information and instructions:

  • For external use only.
  • Before applying Trigaine (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 Trigaine (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 Trigaine (Azelaic Acid) Gel.
  • Cosmetics may be applied after the application of Trigaine (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 Trigaine (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.
  • Trigaine (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 Trigaine (Azelaic Acid) Gel.
    • Pump instructions:
      • Remove the cap before use. Depress the pump to dispense a small amount of Trigaine (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

Trigaine 50 Gram Carton

NDC 50419-825-02

For Dermatologic Use Only

Not For Ophthalmic Use

Trigaine (Azelaic Acid) ®

(azelaic acid) Gel 15%

50 grams

50 g Carton

Minoxidil:


Pharmacological action

Trigaine 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 Trigaine (Minoxidil) new hair growth stops, and after 3-4 months may restore the original appearance.

The exact mechanism of action of Trigaine (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 Trigaine (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 Trigaine (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 Trigaine (Minoxidil) in the serum is determined by its rate of absorption through the skin. After the termination of this medication usage approximately 95% of Trigaine (Minoxidil) subjected to systemic absorption, is excreted in 4 days.

Why is Trigaine prescribed?

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

Dosage and administration

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

Trigaine (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.

Trigaine contraindications

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

Using during pregnancy and breastfeeding

Trigaine 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 Trigaine (Minoxidil) should be discontinued and if necessary, prescribed the appropriate therapy.

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

Trigaine drug interactions

With the simultaneous application of Trigaine (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 Trigaine (Minoxidil).

Trigaine 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:


Trigaine information

Trigaine (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).

Trigaine indications

Trigaine (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.

Trigaine warnings

Trigaine (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 Trigaine (Tretinoin) if you are currently nursing an infant.

During your treatment with Trigaine (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 Trigaine (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 Trigaine (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.

Trigaine 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 Trigaine (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 Trigaine (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.

Trigaine 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 Trigaine (Tretinoin) that you have been prescribed without your physician's approval.

Trigaine 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.

Trigaine missed dose

In order to get the most benefits from your treatment with Trigaine (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.

Trigaine side effects

Alert your doctor if you experience anything bothersome during your treatment with Trigaine (Tretinoin).

Trigaine drug reactions

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

Trigaine pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Trigaine available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Trigaine destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Trigaine Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Trigaine pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."SKIN-LUBE (ALCOHOL) OINTMENT [PERFORMANCE HEALTH LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."FINACEA (AZELAIC ACID) GEL [BAYER HEALTHCARE PHARMACEUTICALS INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Trigaine?

Depending on the reaction of the Trigaine after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Trigaine not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Trigaine addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Trigaine, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Trigaine consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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