Important Safety Information

MINOXIDIL CONTRAINDICATIONS:

• Oral minoxidil is contraindicated in pheochromocytoma (a type of adrenal gland tumor), because it may stimulate secretion of catecholamines from the tumor through its antihypertensive action.
• Minoxidil is contraindicated in those patients with a history of hypersensitivity (allergy) to minoxidil.

MINOXIDIL WARNINGS AND PRECAUTIONS:

• Salt and water retention: Oral minoxidil can cause salt and water retention. Monitor for fluid retention and increase in body weight. If you quickly gain five or more pounds, or if there is any swelling or puffiness in the face, hands, ankles, or stomach area, this could be a sign that you are retaining body fluids. Should this occur, contact your healthcare provider immediatel
• Increased heart rate (tachycardia): Oral minoxidil can increase your heart rate. You should measure your heart rate by counting your pulse rate while you are resting. If you have an increase of 20 beats or more per minute over your normal pulse, contact your healthcare provider immediately.
• Pericarditis, pericardial effusion and tamponade: Oral minoxidil can cause an accumulation of fluids in the sac surrounding the heart. Monitor for sharp pain in the chest, arm, or shoulder; signs of severe indigestion; or shortness of breath, dizziness, lightheadedness, and fainting. These could be signs of serious heart problems and you should seek immediate emergency care should any of these occur.
• Hazard of rapid control of blood pressure: Oral minoxidil can lower your blood pressure. A sudden or too large of a drop in blood pressure can lead to fainting, heart attack, and loss of blood flow to certain organs.

MINOXIDIL SIDE EFFECTS:

Most common adverse reactions are hypertrichosis (increased hair growth on the face or body), lightheadedness, palpitations or tachycardia, headaches, leg swelling or fluid retention (edema), swelling around the eyes, insomnia, nausea, bloating, and flushing.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

MINOXIDIL DRUG INTERACTIONS:

• Interaction with guanethidine: Although minoxidil does not itself cause orthostatic hypotension, its administration to patients already receiving guanethidine can result in profound orthostatic effects. If at all possible, guanethidine should be discontinued well before minoxidil is begun. Where this is not possible, minoxidil therapy should be started in the hospital and the patient should remain institutionalized until severe orthostatic effects are no longer present or the patient has learned to avoid activities that provoke them.

MINOXIDIL USE IN SPECIFIC POPULATIONS:

• Pregnancy: Oral minoxidil is a Pregnancy Category C medication. Oral minoxidil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Nursing Mothers: Because of the potential for adverse effects in nursing infants from minoxidil absorption, minoxidil should not be administered to a nursing woman.
• Kidney disease: Renal failure or dialysis patients may require smaller doses of minoxidil and should have close medical supervision to prevent exacerbation of renal failure or precipitation of cardiac failure.
• Use after heart attack: Oral minoxidil not been used in patients who have had a myocardial infarction (heart attack) within the preceding month. It is possible that a reduction of arterial pressure with minoxidil might further limit blood flow to the myocardium, although this might be compensated by decreased oxygen demand because of lower blood pressure.

TADALAFIL CONTRAINDICATIONS:

• Administration of tadalafil to patients using any form of organic nitrate is contraindicated. Tadalafil was shown to potentiate the hypotensive effect of nitrate.
• History of known serious hypersensitivity reaction (allergy) to tadalafil.

TADALAFIL WARNINGS AND PRECAUTIONS

• Patients should not use tadalafil if sex is inadvisable due to cardiovascular status.
• Use of tadalafil with alpha blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension.
• Tadalafil is not recommended in combination with alpha blockers for the treatment of BPH because efficacy of the combination has not been adequately studied and because of the risk of blood pressure lowering. Caution is advised when tadalafil is used as a treatment for ED in men taking alpha blockers.
• If taking potent inhibitors of CYP3A4, dose should be adjusted: tadalafil for use as needed: ≤10 mg every 72 hours. For once daily use: dose not to exceed 2.5 mg.
• Patients should seek emergency treatment if an erection lasts >4 hours. Use tadalafil with caution in patients predisposed to priapism.
• Patients should stop tadalafil and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of Non Arteritic Ischemic Optic Neuropathy (NAION). Discuss increased risk of NAION in patients with history of NAION.
• Patients should stop tadalafil and seek prompt medical attention in the event of sudden decrease or loss of hearing.
• Prior to initiating treatment with tadalafil for BPH, consideration should be given to other urological conditions that may cause similar symptoms.

TADALAFIL DRUG INTERACTIONS:

• Tadalafil can potentiate the hypotensive effects of nitrates, alpha blockers, antihypertensives or alcohol.
• CYP3A4 inhibitors (e.g. ketoconazole, ritonavir) increase tadalafil exposure. For concomitant use with potent CYP3A4 inhibitors, dose adjustment may be needed.
• CYP3A4 inducers (e.g. rifampin) decrease tadalafil exposure.

TADALAFIL USE IN SPECIFIC POPULATIONS:

• Hepatic Impairment:
  • Mild or Moderate: Dosage adjustment may be needed.
  • Severe: Use is not recommended.
• Renal Impairment:
  • Patients with creatinine clearance 30 to 50 mL/min: Dosage adjustment may be needed.
  • Patients with creatinine clearance less than 30 mL/min or on hemodialysis: For use as needed: Dose should not exceed 5 mg every 72 hours. Once daily use is not recommended.