Balback M

Uses

Balback M is used for the treatment of androgenic alopecia in males and females and stabilisation of hair loss in patients with androgenic alopecia, and also of alopecia areata.

Balback M is also used to associated treatment for these conditions: Androgenetic Alopecia, Severe, symptomatic Hypertension

How Balback M works

Balback M is thought to promote the survival of human dermal papillary cells (DPCs) or hair cells by activating both extracellular signal-regulated kinase (ERK) and Akt and by preventing cell death by increasing the ratio of BCl^-2/Bax. Balback M may stimulate the growth of human hairs by prolonging anagen through these proliferative and anti-apoptotic effects on DPCs. Balback M, when used as a vasodilator, acts by opening adenosine triphosphate-sensitive potassium channels in vascular smooth muscle cells. This vasodilation may also improve the viability of hair cells or hair follicles.

Dosage

Balback M dosage

Balback M topical solution is for external use only and should be applied when the hair and scalp are clean and dry. Apply 1 ml (7 sprays) of Balback M topical solution twice daily at 12-hour intervals to the scalp, beginning at the centre of the affected area and spreading the solution out to cover the entire affected area. The total daily application dose should not exceed 2 ml.

For the best results, Balback M topical solution should be allowed to remain on the scalp for about 4 hours before washing. The night-time application should be done 2-4 hours before going to bed to allow the solution to dry out. Balback M topical solution should not be massaged into the scalp, but applied lightly. A hair dryer should not be used to speed up the drying of the solution as it may decrease the effectiveness. Balback M topical solution should not be mixed with any hair oil. The drug should not be used more than two times a day, or be taken orally or applied to any other part of the body to avoid the risk of adverse effects and unwanted hair growth. More frequent use or longer application time have no effect on hair growth. In case of missing any daily applications of Balback M topical solution, the patient should continue with the next application.

Hands should be washed immediately if Balback M topical solution is applied with the fingertips. Clinical experience with Balback M indicates that twice-daily applications for 4 months or more may be required before there is evidence of hair growth. To arresthair fall, Balback M topical solution should be used for not less than 45 days. Depending upon the severity of hair loss or type and extent of baldness, particular strength of Balback M topical solution may be selected.

Side Effects

Commonly encountered side effects in clinical trials with Balback M topical solution were minor dermatological reactions. Dermatitis or hypertrichosis may occur. These incidences may occur in 0.1–5% of patients.

Toxicity

Oral LD₅₀ in rats has ranged from 1321-3492 mg/kg; in mice, 2456-2648 mg/kg. Side effects include cardiovascular effects associated with hypotension such as sudden weight gain, rapid heart beat, faintness or dizziness.

Precaution

Balback M topical solution is more likely to cause scalp irritation. If scalp irritation continues or worsen, use of Balback M topical solution should be stopped.

Interaction

Balback M topical solution should not be used along with other topical agents known to alter the stratum corneum barrier such as tretinoin or dithranol, due to the enhanced absorption of Balback M. Although there is no clinical evidence, there exists the theoretical possibility of absorbed Balback M potentiating orthostatic hypotension caused by peripheral vasodilators.

Food Interaction

• Take with or without food. The absorption is unaffected by food.

Balback M Drug Interaction

Unknown: aspirin, aspirin, nebivolol, carvedilol, rosuvastatin, omega-3 polyunsaturated fatty acids, insulin glargine, furosemide, atorvastatin, metoprolol, metoprolol, esomeprazole, amlodipine, clopidogrel, pantoprazole, levothyroxine, acetaminophen, cyanocobalamin, ascorbic acid, cholecalciferol

Balback M Disease Interaction

Major: fluid retention/congestive heart failure, ischemic heart disease, pheochromocytomaModerate: renal failure/dialysis

Elimination Route

Balback M is at least 90% absorbed from the GI tract in experimental animals and man.

Half Life

4.2 hours

Pregnancy & Breastfeeding use

Balback M topical solution should not be used during pregnancy and lactation.

Contraindication

• Patients with cardiac abnormalities
• Children below 18 years of age
• Patients using occlusive dressings or other medicines on the scalp
• Patients with red, inflamed infection, or irritated or painful scalp (including psoriasis & sunburn)

Acute Overdose

Increased systemic absorption of Balback M may potentially occur if higher-than-recommended doses of Balback M are applied to larger surface areas of the body or areas other than the scalp. There are no known cases of Balback M overdosage resulting from topical administration of Balback M.

Signs and symptoms of Balback M overdosage would primarily be cardiovascular effects associated with sodium and water retention, and tachycardia. Fluid retention can be managed with appropriate diuretic therapy. Clinically significant tachycardia can be controlled by administration of a beta-adrenergic blocking agent.

Storage Condition

Store at a cool and dry place, protected from light. Keep out of the reach of the children.

Innovators Monograph

You find simplified version here Balback M