Sanbe-Hair

Sanbe-Hair

Manufacturer:

Sanbe

Marketer:

Sanbe
Full Prescribing Info
Contents
Minoxidil, finasteride.
Description
Composition: Minoxidil 5.0% w/v, Finasteride 0.1% w/v, Base Q.S.
Action
Pharmacology: Pharmacodynamics: When applied topically, Minoxidil topical solution has been shown to stimulate hair growth in individuals with androgenetic alopecia (male pattern baldness). Although the exact mechanism of action of Minoxidil in the treatment of androgenetic alopecia is not known, there may be more than one mechanism by which Minoxidil stimulates hair growth. They include: (a) vasodilation of the microcirculation around the hair follicles which may stimulate hair growth; (b) direct stimulation of the hair follicle cells to enter into a proliferative phase: resting phase (telogen) follicles being stimulated to pass into active phase (anagen) follicles; (c) alteration of the effect of androgens on genetically predetermined hair follicles: Minoxidil may affect the androgen metabolism in the scalp by inhibiting capacity of androgens to affect the hair follicles.
Finasteride is a type II 5-α-reductase inhibitor, an intracellular enzyme that converts androgen testosterone to 5-α-dihydrotestosterone (DHT). Inhibition of 5-α-reductase inhibitors will block the conversion of testosterone to DHT, thereby reducing the concentration of DHT in serum and tissue.
In men with male pattern hair loss (androgenetic alopecia), the balding scalp contains miniaturized hair follicles and increased amounts of DHT compared with hairy scalp. Application of Finasteride decreases scalp DHT concentration in these man, which may contribute to the treatment effect of Finasteride. By this mechanism, Finasteride appears to interrupt a key factor in the development of androgenetic alopecia in those patients who are genetically predisposed.
Pharmacokinetics: Following topical application of Minoxidil topical solution, Minoxidil is poorly absorbed from normal intact skin, with an average of 1.4% (range 0.3% to 4.5%) of the total applied dose reaching the systemic circulation. The effects of concomitant dermal diseases or occlusion on absorption are unknown. Serum Minoxidil levels resulting from topical administration are governed by the drug's percutaneous absorption rate; increases in surface area of application do not result in proportionate increases in the serum Minoxidil level. Steady state is achieved by the end of the third dosing interval (36 hours) when the drug is administered twice daily. Approximately 95% of the systematically absorbed Minoxidil from topical dosing is eliminated within 4 days. The metabolic biotransformation of Minoxidil absorbed following topical application has not been fully determined.
Known metabolites exert much less pharmacologic effect than Minoxidil itself, and all are excreted principally in the urine. Minoxidil does not bind to plasma proteins; its renal clearance corresponds to glomerular filtration rate and it does not cross the blood brain barrier. Minoxidil and its metabolites are hemodialyzable, although this does not rapidly reverse its pharmacological effect.
Increased hair growth has not been associated with increased systemic absorption of topical Minoxidil. The onset of hair growth stimulation requires twice daily applications of Minoxidil topical solution for 4 or more months and is variable among patients. Upon discontinuation of topically applied Minoxidil, new hair growth has been subjectively reported to stop and restoration of pretreatment appearance to occur within 3 to 4 months.
The pharmacokinetics of Finasteride following topical administration has not been evaluated systematically. However, it is expected that it will be poorly absorbed from normal intact skin, with a minimal of the total applied dose reaching the systemic circulation.
Indications/Uses
SANBE-HAIR topical solution is indicated for the treatment of androgenetic alopecia (male pattern baldness) in men.
Dosage/Direction for Use
For External use, only as directed.
For the adult men age group with above 45 years, the efficacy may be lower.
A total dose of 1 mL SANBE-HAIR topical solution should be applied twice a day to the affected scalp, beginning at the centre of the baldness or scalp area. This dose should be used regardless of the size of the affected area. The total daily dose should not exceed 2 ml. SANBE-HAIR topical solution should be applied when the hair and scalp are thoroughly dry. Do not use a hairdryer to speed the drying of the topical solution, because blowing air on the scalp may decrease the effectiveness of the drug. SANBE-HAIR topical solution should be allowed to completely dry for 2 to 4 hours after applying it, including before going to bed. SANBE-HAIR topical solution may stain clothing, hats or bed linen if the hair or scalp is not fully dry after using the medicine.
SANBE-HAIR topical solution shall not be mixed with any hair oil nor shall it be applied to other body parts. Hands should be thoroughly washed after application.
Clinical experience with Minoxidil and Finasteride indicates that application for 4 or more months maybe required before evidence of hair growth stimulation can be expected. Onset and degree maybe variable among patients. Though relapse to pretreatment appearance following discontinuation of Minoxidil solution use has been subjectively reported to occur within 3 to 4 months, it is expected that SANBE-HAIR topical solution shall not demonstrated the same due to additional benefits of Finasteride.
Overdosage
Accidental ingestion of SANBE-HAIR topical solution which contains Minoxidil that may produce systemic effects related to the vasodilatory action of Minoxidil. There have been only a few instances of deliberate or accidental overdosage with oral Minoxidil. Signs and symptoms of drug overdosage would most likely include cardiovascular effects associated with fluid retention, lowered blood pressure and tachycardia. Fluid retention can be managed with appropriate diuretic therapy. Tachycardia can be controlled by administration of a beta-adrenergic blocking agent.
There have been no reports of specific adverse events with high doses of Finasteride. Currently, no specific treatment for an overdose with Finasteride is recommended.
Contraindications
Hypersensitivity to Minoxidil, Finasteride or any of the constituents of the solution.
Women in reproductive age and nursing women.
Pregnancy.
Special Precautions
There is some absorption of Minoxidil from the skin and the potential exists for systemic effect such as tachycardia, angina, edema or potentiation of the orthostatic hypotension produced by Guanethidine. Patients should be observed periodically for any suggestion of systemic effects of Minoxidil. In the event of systemic side effects discontinue administration of this product. If necessary, fluid retention and edema can be managed with diuretic treatment. Tachycardia and angina can be controlled by administration of beta-adrenergic blocking drugs or other sympathetic nervous system suppressants.
Though not expected, Finasteride on percutaneous absorption can suppress the serum DHT levels and may cause systemic side effects i.e. decreased libido, erectile dysfunction, ejaculation disorders, breast tenderness or enlargement and testicular pain. Patients should be observed periodically for any suggestion of such a systemic effect. Special caution should be taken for the patients with liver function abnormalities, because large amounts of Finasteride is metabolized in the liver.
Patients with Underlying Cardiovascular Disease: Since this product contains Minoxidil, patients should not use this product if they have a history of underlying coronary artery disease, cardiac dysrhythmias, congestive heart failure, or valvular heart disease. Patients with hypertension, including those under treatment with antihypertensive agents, should be monitored closely and their medication adjusted if necessary. This product should be used with caution in patients with history of any other cardiovascular disease or if present.
Effect on laboratory tests result: Serum Prostate Specific Antigen (PSA) Levels: Percutaneous absorption of Finasteride may affect serum PSA levels. These shall be taken into account for proper interpretation of serum PSA when evaluating men treated with this product.
Use in Pregnancy and Lactation: This product should not be used by pregnant or nursing women.
This is due lo the ability of Type II 5-α-reductase inhibitors to inhibit the conversion of testosterone to DHT. Finasteride may cause abnormalities of the external genital of male fetus of a pregnant woman who receives Finasteride.
Use in Children: Safety and effectiveness of this product in patients under 18 years old has not been established.
Geriatrics: Studies involving subject over the age of 60 years have not been performed hence the safety and effectiveness of this product in these patients has not been established.
Use In Pregnancy & Lactation
Use in Pregnancy and Lactation: This product should not be used by pregnant or nursing women.
This is due lo the ability of Type II 5-α-reductase inhibitors to inhibit the conversion of testosterone to DHT. Finasteride may cause abnormalities of the external genital of male fetus of a pregnant woman who receives Finasteride.
Adverse Reactions
The most frequently encountered adverse effects in clinical trials with Minoxidil topical solution were minor dermatologic reactions. Local irritation was the most common adverse reaction reported, including scaling, erythema/flushing, dermatitis, dry skin, hypertrichosis (in areas other than where Minoxidil topical solution was applied), burning sensation and rash.
Infrequent adverse reactions reported with Minoxidil solution include allergic reactions (sensitivity, hives, generalized erythema and facial swelling), dizziness, tingling sensation, headache, weakness, neuritis, edema, eye irritation, altered taste, ear infection (otitis externa), and visual disturbances. Also rarely reported adverse reactions included alopecia, hair abnormalities, chest pain, blood pressure changes, pulse changes, hepatitis and kidney stones.
The frequently reported adverse events with Finasteride oral administration are impotence, decreased libido, ejaculation disorders, breast enlargement or tenderness and skin rash. These side effects resolve mostly despite continuation of therapy. Medical doctor should instruct their patients to promptly report any changes in their breast such as lumps, pain or nipple discharge as breast changes including breast enlargement, tenderness and neoplasm have been reported during Finasteride treatment.
Drug Interactions
There are currently no known drug interactions associated with the use of topical Minoxidil or Finasteride administration. Although it has not been clinically demonstrated, there exist the possibility of Minoxidil potentiating orthostatic hypotension in patients concurrently taking Guanethidine.
This product should not be used together with other topical drug that used in scalp. Topical drugs like corticosteroids, tretinoin, dithranol or petrolatum can change stratum corneum which leads to increase the absorption of Minoxidil simultaneously. Although it has not been proven clinically, theoretically there is possibility of absorption of Minoxidil which has the potential to cause orthostatic hypotension due to peripheral vasodilation.
Caution For Usage
How to Use: 1. Open the glass bottle containing SANBE-HAIR topical solution.
2. Take the dropper provided in the SANBE-HAIR topical solution box and insert the dropper into the glass bottle.
3. Take the content into the dropper to fill the volume up to 1 mL marked line.
4. Pour the content of the dropper aiming towards the center of the bald area of the scalp and spread evenly with fingertips.
Storage
Store at temperature below 30°C, away from light.
Keep out of reach of children.
Use within 4 months after the bottle is opened.
ATC Classification
D11AX01 - minoxidil ; Belongs to the class of other dermatologicals.
D11AX10 - finasteride ; Belongs to the class of other dermatologicals.
Presentation/Packing
Topical soln 60 mL x 1's.
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