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JAMP MINOXIDIL 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: JAMP Minoxidil Solution (2% minoxidil topical solution) is indicated for: • the treatment of male androgenetic alopecia (male pattern hair loss) on the top of the scalp (vertex). JAMP Minoxidil Solution is not approved for use in women. The effectiveness of minoxidil topical solution in the treatment of receding…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • FOR EXTERNAL USE ONLY. Do not ingest. Use JAMP Minoxidil Solution only as directed. Apply JAMP Minoxidil Solution 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 JAMP Minoxidil Solution (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). After applying JAMP Minoxidil Solution, wash hands thoroughly. Do not apply JAMP Minoxidil Solution to any other area of the body. Health Canada has not authorized an indication for pediatric use.
4 Administration Pump-Spray Applicator 1. Remove the outer cap. 2. After opening the bottle, discard 3 sprays in order to obtain a uniform spray of the product. 3. After aiming the pump at the center of the thinning or bald area of the scalp, press the pump once and spread JAMP Minoxidil Solution with fingertips to cover all the thinning or bald area.
Repeat for a total of 6 squirts, to apply a total dose of 1 mL. Avoid breathing spray mist. 4. Replace the cap. 5 Missed Dose If a dose is missed, JAMP Minoxidil Solution 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. JAMP Minoxidil Solution (Minoxidil Topical Solution) Page 6 of 36
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 placebo controlled clinical studies involving 2386 patients (1188 minoxidil topical solution and 1198 placebo) and are listed below in Table 1.
3 Less Common Clinical Trial Adverse Reactions JAMP Minoxidil Solution (Minoxidil Topical Solution) Page 10 of 36 Adverse Events seen in less than 1% of males using minoxidil topical solution 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. 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 • JAMP Minoxidil Solution is for external use only. Apply only to scalp. Do not ingest. • Before applying JAMP Minoxidil Solution, 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. • JAMP Minoxidil Solution 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 minoxidil topical solution 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 JAMP Minoxidil Solution and consult their doctor. • JAMP Minoxidil Solution 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.
• Cases of hypertrichosis have been reported in infants following skin contact with minoxidil application site of patients (caregivers) using topical minoxidil. Hypertrichosis was reversible, within months, when infants were no longer exposed to minoxidil.
Contact between children and minoxidil application sites should be avoided. Cardiovascular • Accidental ingestion may cause serious cardiac adverse events. • Patients with known cardiovascular disease or cardiac arrhythmia should contact a physician before using JAMP Minoxidil Solution.
JAMP Minoxidil Solution (Minoxidil Topical Solution) Page 8 of 36 • Although the following systemic effects have not been associated with the topical use of minoxidil topical solution, there is some absorption of minoxidil from the skin and the potential exists for systemic effects such as salt and water retention, hypertension, tachycardia, angina, and edema.
JAMP
Minoxidil Solution is contraindicated: • 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. JAMP Minoxidil Solution 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 JAMP Minoxidil Solution.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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, where the numerator represents the total number of reported Company Adverse Events (AEs) under a given preferred term (PT) or medical concept and the denominator represents exposure data calculated from sales data.
Very common ≥1/10 Common ≥1/100 and < 1/10 Uncommon ≥1/1,000 and <1/100 JAMP Minoxidil Solution (Minoxidil Topical Solution) Page 11 of 36 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 Eye Disorders Very rare Eye irritation Cardiac Disorders Very rare Tachycardia Very rare Palpitations Vascular Disorders Very rare Hypotension Gastrointestinal Disorders Very rare Nausea Very rare Vomiting Skin and Subcutaneous Tissue Disorders 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) Very rare Alopecia Very rare Hair colour changes JAMP Minoxidil Solution (Minoxidil Topical […]
• The patient should stop using JAMP Minoxidil Solution 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.
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 JAMP Minoxidil Solution should be discontinued in the event of systemic effects and/or severe dermatologic reactions. 1 Pregnant Women There are no adequate and well-controlled studies in pregnant women using minoxidil topical solution.
These products should not be used in pregnant women. 2 Breast-feeding There are no adequate and well controlled studies in breastfeeding women. Systemically absorbed minoxidil is secreted in human milk. JAMP Minoxidil Solution should not be used in nursing women.
3 Pediatrics Pediatrics (<18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of minoxidil topical solution in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.
1 Pediatrics. Accidental ingestion may cause serious cardiac adverse events. Therefore, this product has to be kept out of the reach of children. See 7 Warnings and Precautions, Cardiovascular. 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.
JAMP Minoxidil Solution should not be used in the male geriatric population.