INTERACTIONS Use of DOPA decarboxylase inhibitors may require dose adjustments for Droxidopa capsule ( 7.2 )
7.1 Drugs that Increase Blood Pressure Administering Droxidopa capsule in combination with other agents that increase blood pressure (e.g., norepinephrine, ephedrine, midodrine, and triptans) would be expected to increase the risk for supine hypertension.
7.2 Parkinson's Medications Dopa-decarboxylase inhibitors may require dose adjustments for Droxidopa capsule.
7.3 Non-selective MAO inhibitors The concomitant use of selective MAO-B inhibitors, such as rasagiline or selegiline, was permitted in the Droxidopa capsule clinical trials. However, based on mechanism of action, the use of non-selective MAO inhibitors and linezolid should be avoided as there is a potential for increased blood pressure when taken with Droxidopa capsule.
7.1 Drugs that Increase Blood Pressure Administering Droxidopa capsule in combination with other agents that increase blood pressure (e.g., norepinephrine, ephedrine, midodrine, and triptans) would be expected to increase the risk for supine hypertension.
7.2 Parkinson's Medications Dopa-decarboxylase inhibitors may require dose adjustments for Droxidopa capsule.
7.3 Non-selective MAO inhibitors The concomitant use of selective MAO-B inhibitors, such as rasagiline or selegiline, was permitted in the Droxidopa capsule clinical trials. However, based on mechanism of action, the use of non-selective MAO inhibitors and linezolid should be avoided as there is a potential for increased blood pressure when taken with Droxidopa capsule.
Droxidopa capsules are contraindicated in patients who have a history of hypersensitivity to the drug or its ingredients [ see Warnings and Precautions ( 5.4 ) ] . History of hypersensitivity to the drug or its ingredients ( 4 )
AND PRECAUTIONS Droxidopa capsule may cause supine hypertension and may increase cardiovascular risk if supine hypertension is not well-managed ( 5.1 ) Hyperpyrexia and confusion ( 5.2 ) May exacerbate symptoms in patients with existing ischemic heart disease, arrhythmias, and congestive heart failure ( 5.3 ) Allergic reactions ( 5.4 )
5.1 Supine Hypertension Droxidopa capsule therapy may cause or exacerbate supine hypertension in patients with nOH. Patients should be advised to elevate the head of the bed when resting or sleeping. Monitor blood pressure, both in the supine position and in the recommended head-elevated sleeping position. Reduce or discontinue Droxidopa capsule if supine hypertension persists. If supine hypertension is not well-managed, Droxidopa capsule may increase the risk of cardiovascular events, particularly stroke.
5.2 Hyperpyrexia and Confusion Postmarketing cases of a symptom complex resembling neuroleptic malignant syndrome (NMS) have been reported with Droxidopa capsule use during post marketing surveillance. Observe patients carefully when the dosage of Droxidopa capsule is changed or when concomitant levodopa is reduced abruptly or discontinued, especially if the patient is receiving neuroleptics. NMS is an uncommon but life-threatening syndrome characterized by fever or hyperthermia, muscle rigidity, involuntary movements, altered consciousness, and mental status changes. The early diagnosis of this condition is important for the appropriate management of these patients.
5.3 Ischemic Heart Disease, Arrhythmias, and Congestive Heart Failure Droxidopa capsule may exacerbate existing ischemic heart disease, arrhythmias, and congestive heart failure. Careful consideration should be given to this potential risk prior to initiating therapy in patients with these conditions.
5.4 Allergic Reactions Hypersensitivity reactions including anaphylaxis, angioedema, bronchospasm, urticaria and rash have been reported in post marketing experience. Some of these reactions resulted in emergency treatment. If a hypersensitivity reaction occurs, discontinue the drug and initiate appropriate therapy. This product contains FD&C Yellow No. 5 (tartrazine) which may also cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity <span class="opacity-50 text-xs">[see Contraindications (4) ]</span> .
5.1 Supine Hypertension Droxidopa capsule therapy may cause or exacerbate supine hypertension in patients with nOH. Patients should be advised to elevate the head of the bed when resting or sleeping. Monitor blood pressure, both in the supine position and in the recommended head-elevated sleeping position. Reduce or discontinue Droxidopa capsule if supine hypertension persists. If supine hypertension is not well-managed, Droxidopa capsule may increase the risk of cardiovascular events, particularly stroke.
5.2 Hyperpyrexia and Confusion Postmarketing cases of a symptom complex resembling neuroleptic malignant syndrome (NMS) have been reported with Droxidopa capsule use during post marketing surveillance. Observe patients carefully when the dosage of Droxidopa capsule is changed or when concomitant levodopa is reduced abruptly or discontinued, especially if the patient is receiving neuroleptics. NMS is an uncommon but life-threatening syndrome characterized by fever or hyperthermia, muscle rigidity, involuntary movements, altered consciousness, and mental status changes. The early diagnosis of this condition is important for the appropriate management of these patients.
5.3 Ischemic Heart Disease, Arrhythmias, and Congestive Heart Failure Droxidopa capsule may exacerbate existing ischemic heart disease, arrhythmias, and congestive heart failure. Careful consideration should be given to this potential risk prior to initiating therapy in patients with these conditions.
5.4 Allergic Reactions Hypersensitivity reactions including anaphylaxis, angioedema, bronchospasm, urticaria and rash have been reported in post marketing experience. Some of these reactions resulted in emergency treatment. If a hypersensitivity reaction occurs, discontinue the drug and initiate appropriate therapy. This product contains FD&C Yellow No. 5 (tartrazine) which may also cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity <span class="opacity-50 text-xs">[see Contraindications (4) ]</span> .