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HAIR REGROWTH FORMULA is a brand name for Minoxidil, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: HAIR REGROWTH FORMULA (2% minoxidil topical solution) is indicated for: the treatment of male androgenetic alopecia (male pattern hair loss) on the top of the scalp (vertex). HAIR REGROWTH FORMULA is not approved for use in women. The effectiveness of minoxidil topical solution in the treatment of receding hairlines…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations HAIR REGROWTH FORMULA is not approved for use in women. FOR EXTERNAL USE ONLY. Use HAIR REGROWTH FORMULA (minoxidil topical solution) only as directed. Apply HAIR REGROWTH FORMULA when the hair and scalp are thoroughly dry.
The safety and efficacy of minoxidil topical solution in users aged under 18 or in men over 65 years of age have not been established. 2 Recommended Dose and Dosage Adjustment A total dose of 1 mL HAIR REGROWTH FORMULA (20 mg minoxidil) should be applied twice per day to the scalp, beginning at the centre of the affected area.
This dose should be used regardless of the size of the affected area. The total daily dose should not exceed 2 mL (40 mg minoxidil). The method of application varies according to the disposable applicator used, as indicated below. After applying HAIR REGROWTH FORMULA, wash hands thoroughly.
Do not apply HAIR REGROWTH FORMULA to any other area of the body. Health Canada has not authorized an indication for pediatric use. 4 Administration A. Pump Spray Applicator Works best for applying HAIR REGROWTH FORMULA to large areas of the scalp.
1) Remove Child-Resistant cap by pushing down while turning the cap anti-clockwise. Retain Child-Resistant cap. 2) Insert the pump-spray applicator into the bottle and screw on tightly. 3) After aiming the pump at the centre of the thinning or bald area of the scalp, press the pump once and spread HAIR REGROWTH FORMULA with fingertips to cover all the thinning or bald area.
Repeat for a total of 4 times to apply a total dose of 1 mL. Avoid breathing spray mist. 4) To retain Child-Resistant feature, remove Pump-Spray applicator and retain for next application. Replace Child-Resistant cap by tightly screwing on in a clockwise direction.
B. Rub-On Applicator Works best for applying HAIR REGROWTH FORMULA to small areas of the scalp. 1) Remove Child-Resistant cap by pushing down while turning the cap anti-clockwise. Retain Child-Resistant cap. 2) Insert the rub-on applicator into the bottle and screw on tightly.
Remove outer cap and keep it. 3) Hold the bottle upright and squeeze it once to half fill the upper chamber. The level of liquid in the chamber will automatically adjust to deliver one full dose (1 mL). 4) Hold the bottle upside down then rub applicator on your scalp to apply HAIR REGROWTH FORMULA over the whole thinning or bald area until the chamber is completely empty.
09%). 43%). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. The occurrence rates of adverse reactions seen in greater than 1% of male patients were obtained from HAIR REGROW TH FORMULA (Minoxidil Topical Solution) Page 9 of 33 placebo controlled clinical studies involving 2386 patients (1188 minoxidil topical solution 2% and 1198 placebo) and are listed below in Table 1.
3 Less Common Clinical Trial Adverse Reactions Adverse Events seen in less than 1% of males using minoxidil topical solution 2% Ear and Labyrinth Disorders: ear infection and ear inflammation. Eye Disorders: conjunctivitis. Gastrointestinal Disorders: abdominal pain, nausea, diarrhoea, vomiting, tonsillitis, gastroenteritis, hemorrhoids, and aphthous stomatitis.
General Disorders and Administration Site Conditions: pyrexia and fatigue. Hepatobiliary disorders: hepatitis. Immune System Disorders: hypersensitivity, seasonal allergy, influenza-like illness, and urticaria. Injury, Poisoning, and Procedural Complications: injury.
Investigations:
Weight increased. Metabolism and Nutritional Disorders: oedema and weight gain. HAIR REGROW TH FORMULA (Minoxidil Topical Solution) Page 10 of 33 Musculoskeletal and Connective Tissue Disorders: myalgia, fracture, arthralgia, musculoskeletal stiffness and myositis, muscle strain, and tendon, bursa, and ligament disorders.
Nervous system Disorders: dizziness, asthenia, headache, insomnia, paresthesia, and sciatica. Renal and urinary Disorders: nephrolithiasis and urethritis. Reproductive System and Breast Disorders: prostatitis and epididymal disorder.
General HAIR REGROWTH FORMULA is for external use only. Apply only to scalp. Before applying HAIR REGROWTH FORMULA, the user should determine that the scalp is normal and healthy. Hands should be washed thoroughly after use. Inhalation of the spray should be avoided.
HAIR REGROWTH FORMULA contain ethanol (alcohol) which will cause burning and irritation of the eye. In the event of accidental contact with sensitive surfaces (eye, abraded skin, mucous membranes), the area should be bathed with large amounts of cool tap water.
Some patients have experienced changes in hair colour and/or texture with HAIR REGROWTH FORMULA use. Shedding of hair may occur within two to six weeks after initiating therapy, likely due to minoxidil’s action on shifting hairs from the resting telogen phase to the growing anagen phase.
If shedding persists for more than two weeks, users should stop applying HAIR REGROWTH FORMULA and consult their doctor. HAIR REGROWTH FORMULA should not be used when there is no family history of hair loss, hair loss is sudden and/or patchy, or the reason for hair loss is unknown.
Cardiovascular Patients with known cardiovascular disease or cardiac arrhythmia should contact a physician before using HAIR REGROWTH FORMULA. Although the following systemic effects have not been associated with the topical use of HAIR REGROWTH FORMULA, there is some absorption of minoxidil from the skin and the potential Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Topical Solution 20 mg/mL (2%) minoxidil Alcohol, propylene glycol, purified water.
HAIR REGROW TH FORMULA (Minoxidil Topical Solution) Page 8 of 33 exists for systemic effects such as salt and water retention, hypertension, tachycardia, angina, and edema. The patient should stop using HAIR REGROWTH FORMULA and see a doctor if hypotension is detected or if the patient is experiencing chest pain, rapid heartbeat, faintness or dizziness, sudden unexplained weight gain, swollen hands or feet, or persistent redness.
HAIR REGROWTH FORMULA is contraindicated: in women. in individuals with a history of hypersensitivity to minoxidil or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
in individuals with treated or untreated hypertension. in individuals whose baldness is not due to hereditary factors. HAIR REGROWTH FORMULA is only effective for the treatment of male vertex alopecia androgenetica. in individuals with any scalp abnormality (including psoriasis and sunburn).
in individuals with a shaved scalp or whose scalp’s skin is broken, inflamed, irritated, infected, or severely sunburned. if occlusive dressings or other topical therapeutic medications for treating disorders of the skin of the scalp are being used.
, cornrowing, tight ponytails), may also cause temporary hair loss which should not be treated with HAIR REGROWTH FORMULA. HAIR REGROW TH FORMULA (Minoxidil Topical Solution) Page 5 of 33
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Minoxidil in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Replace outer cap over the rub-on applicator when not in use. 5) To retain Child-Resistant feature, remove Rub-On applicator and retain for next application. Replace Child-Resistant cap by tightly screwing on in a clockwise direction.
C. Extended Spray-Tip Applicator Works best for applying HAIR REGROWTH FORMULA to small areas of the scalp or under hair. HAIR REGROW TH FORMULA (Minoxidil Topical Solution) Page 6 of 33 1) Remove Child-Resistant cap by pushing down while turning the cap anti-clockwise.
Retain Child-Resistant cap. 2) Insert the pump-spray applicator into the bottle and screw on tightly. 3) Remove small spray head from top of pump-spray applicator. 4) Fit the extended spray-tip applicator onto the spray shaft and push down firmly.
5) Remove the small cap on the end of the extended tip and keep it. 6) After aiming the applicator at the centre of the thinning or bald area of the scalp, press the pump once and spread HAIR REGROWTH FORMULA with fingertips to cover all the thinning or bald area.
Repeat for a total of 4 times to apply a total dose of 1 mL. Avoid breathing spray mist. 7) To retain Child-Resistant feature, remove Extended Spray-Tip applicator and retain for next application. Replace Child-Resistant cap by tightly screwing on in a clockwise direction.
5 Missed Dose If a dose is missed, HAIR REGROWTH FORMULA should be applied as soon as remembered, if within a few hours of the time usually applied. Do not apply if it is almost time for the next dose. If a dose is missed, the amount used in the next regular dose should not be doubled.
Respiratory, Thoracic, and Mediastinal Disorders: pulmonary congestion, sneezing, pharyngitis, and bronchitis. Skin and Subcutaneous Tissue Disorders: eczema, hypertrichosis, seborrhea, folliculitis, dry skin, dermatitis, erythema, skin burning sensation, cellulitis, and skin irritation.
Vascular Disorders: hypotension, blood pressure increased, chest discomfort, tachycardia, and heart rate increased/decreased. 5 Post-Market Adverse Reactions The following adverse drug reactions (ADRs) have been identified with the application of topical minoxidil during post-marketing use.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the use of the drug. In Table 2 below, the ADRs are presented with ADR frequency categories estimated from spontaneous reporting rates according to the following convention: Very common ≥1/10 Common ≥1/100 and < 1/10 Uncommon ≥1/1,000 and <1/100 Rare ≥1/10,000 and <1/1,000 Very rare <1/10,000 Not known (cannot be estimated from the available data) Table 2: Adverse Drug Reactions Identified During Post-Marketing Experience with Topical Minoxidil by Frequency Category Estimated from Spontaneous Reporting Rates System Organ Class Adverse Event Preferred Term Immune System Disorders Very rare Very rare Very rare Angioedema (the manifestations of angioedema may include the following: Lip oedema, Oedema mouth, Oropharyngeal swelling, Pharyngeal oedema, and Tongue oedema) Hypersensitivity (the manifestations of hypersensitivity reactions may include the following: Face oedema, Generalised erythema, Pruritus generalised, and Throat tightness) Dermatitis contact Psychiatric Disorders Very rare Depressed mood Nervous System Disorders Very rare Dizziness HAIR REGROW TH FORMULA (Minoxidil Topical Solution) Page 11 of 33 System Organ Class Adverse Event Preferred Term Eye Disorders Very rare Eye irritation Cardiac Disorders Very rare Very rare Tachycardia Palpitations Vascular Disorders Very rare Hypotension Gastrointestinal Disorders Very rare Very rare Nausea Vomiting Skin and Subcutaneous Tissue Disorders Very rare Very rare Very rare Very rare Application site reaction (these sometimes involve nearby structures like the ears and face and typically consist of pruritus, irritation, pain, rash, oedema, dry skin, and erythema but can sometimes be more severe and include exfoliation, dermatitis, blistering, bleeding, and ulceration) Alopecia Hair colour changes Hair texture abnormal General Disorders and Administration Site Conditions Very rare Chest pain
Monitoring and Laboratory Tests Patients should be monitored for signs of systemic effects of minoxidil such as hypotension, chest pain, rapid heartbeat, faintness or dizziness, sudden unexplained weight gain, swollen hands or feet, persistent redness or irritation of the scalp.
The use of HAIR REGROWTH FORMULA should be discontinued in the event of systemic effects and/or severe dermatologic reactions. 1 Pregnant Women HAIR REGROWTH FORMULA is not approved for use in women. 2 Breast-feeding HAIR REGROWTH FORMULA is not approved for use in women.
3 Pediatrics Pediatrics (<18 years of age): The efficacy and safety of minoxidil topical solution in children under 18 years of age have not been established. HAIR REGROWTH FORMULA should not be used in the pediatric population. 4 Geriatrics Geriatrics (> 65 years of age): The efficacy and safety of minoxidil topical solution in men over 65 years of age have not been established.
HAIR REGROWTH FORMULA should not be used in the male geriatric population.