Loniten (Minoxidil)

Prescription Required
Brand
Dose Size & Price Qty
2.5mg
10mg
Generic
Dose Size & Price Qty
2.5mg
10mg
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Fact Table

Fact Table
Formula C9H15N5O
License FDA approved (Loniten NDA 018154; original approval 1979); Health Canada marketed as Loniten 2.5 mg and 10 mg tablets
Bioavailability At least 90% absorbed orally from the gastrointestinal tract
Legal status Prescription only (Rx; oral tablets). Topical minoxidil =5% may be non-prescription in Canada
Chemical Name 2,4-Pyrimidinediamine, 6-(1-piperidinyl)-, 3-oxide; 6-(piperidin-1-yl)pyrimidine-2,4-diamine 3-oxide
Elimination half-life Approximately 4.2 hours; antihypertensive effect may persist for several days
Dosage (Strength) 2.5 mg and 10 mg oral tablets; adults and children over 12 years: initial 5 mg once daily, usual effective range 10–40 mg/day, maximum 100 mg/day; usually given with a diuretic and beta-blocker or other sympathetic suppressant
Pregnancy Pregnancy Category C in older labeling; use only if potential benefit justifies fetal risk. Neonatal hypertrichosis has been reported after exposure during pregnancy
Brands Loniten; Minodyl; Rogaine/Regaine topical products; generic minoxidil oral tablets and topical solution/foam products
Protein binding Does not bind to plasma proteins; negligible protein binding
PubChem CID 4201
MedlinePlus a682608
ChEBI 6942
ATC code C02DC01; D11AX01 for topical dermatological minoxidil
DrugBank DB00350
KEGG D00418
Routes of administration By mouth (oral tablets); topical cutaneous solution/foam for hair regrowth products

Loniten (minoxidil) is a prescription oral drug used to treat severe high blood pressure when other medicines have not worked well. It relaxes and widens small blood vessels, making it easier for the heart to pump blood and lowering blood pressure. Because it can cause serious side effects, it is usually reserved for adults or children whose high blood pressure is dangerously high. Loniten tablets are not approved for hair loss.

Directions

Loniten is taken by mouth, usually once per day. Some people may split the dose into two doses if blood pressure drops too much after one dose.

Adults and children over 12 usually start with 5 mg once daily, and the dose may be increased slowly to 10 mg, 20 mg, or 40 mg per day as needed.

Most people take 10 to 40 mg per day, and the highest recommended dose is 100 mg per day.

Children under 12 are dosed by body weight, usually starting at 0.2 mg/kg once daily, with a maximum of 50 mg per day.

Doses are usually increased no more often than every 3 days, unless faster blood pressure control is needed.

Loniten is typically taken with other blood pressure medicines. Take it exactly as directed by a healthcare provider.

Ingredients

The active ingredient in Loniten is minoxidil. The inactive ingredients may include anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. Exact inactive ingredients may vary.

Cautions

Before using this medication, you may want to consult a healthcare provider about the following:

  • Any existing health conditions
  • Any allergies
  • A list of all medications currently being taken

Loniten carries a boxed warning about serious heart risks. It can cause fluid build-up around the heart (pericardial effusion), which can sometimes lead to a dangerous effect on the heart called cardiac tamponade. It can also worsen chest pain (angina) in people with coronary artery disease.

Loniten almost always needs to be taken with a diuretic (often a loop diuretic such as furosemide) to prevent fluid retention and to lower the risk of swelling, weight gain, and heart failure.

Loniten also needs to be taken with a beta-blocker or another medicine that slows the heart rate, since it raises the heart rate and can otherwise cause angina or increase stress on the heart.

Watch for signs of fluid build-up around the heart, including new or worsening shortness of breath, chest discomfort, swelling of the legs or abdomen, or unusual fatigue.

Loniten should not be given with guanethidine if at all possible, because the combination can cause severe drops in blood pressure when standing up.

Use with caution in people with kidney problems or those on dialysis, who often need lower doses and close monitoring.

Loniten has not been studied in people who had a heart attack within the past month, and it is generally avoided in that situation. Patients with severely high blood pressure should be started on Loniten in the hospital.

Increased body hair growth (hypertrichosis) is very common and not the same as scalp hair growth. It usually starts within 3 to 6 weeks of beginning therapy, often appearing on the temples, between the eyebrows, on the cheeks, and later on the arms, legs, and back. It is reversible and slowly fades over 1 to 6 months after stopping the medication.

Do not use Loniten oral tablets to try to treat hair loss. Only the topical minoxidil products are approved for hair growth.

Babies born to mothers who took minoxidil during pregnancy may be born with excess body hair (neonatal hypertrichosis). Minoxidil passes into breast milk and is generally not recommended while breastfeeding.

Contraindications

Avoid taking or using this medication if any of the following apply:

  • Pheochromocytoma (a tumor of the adrenal gland). Minoxidil may stimulate the tumor to release blood-pressure-raising hormones.
  • A known allergy or hypersensitivity to minoxidil or to any of the inactive ingredients in Loniten.

Side Effects

Common side effects of Loniten include:

  • Increased body hair growth, usually on the face, arms, legs, and back
  • Salt and water retention with swelling and weight gain
  • Faster heart rate or palpitations
  • Nausea or upset stomach
  • Headache
  • Dizziness or lightheadedness
  • Skin rash
  • Tender or enlarged breasts in some patients

Get medical help immediately for signs of fluid build-up around the heart or worsening heart function, such as new or worsening chest pain, shortness of breath, fast or irregular heartbeat, sudden swelling of the legs or abdomen, dizziness, or fainting.

Other serious problems can include pericarditis, pericardial effusion with tamponade, congestive heart failure from fluid overload, severe drops in blood pressure (especially when getting up), and signs of a serious allergic reaction such as rash, swelling of the face, lips, tongue, or throat, or trouble breathing.

References

  • Loniten Highlights of Prescribing Information. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; 2015.
  • Minoxidil Tablets Drug Label Information. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; 2015.

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