PARNATE (Page 4 of 7)
7 DRUG INTERACTIONS
7.1 Clinically Significant Drug Interactions
Tables 3 and 4 lists drug classes and individual products, respectively, with a potential for interaction with PARNATE, describes the predominant observed or anticipated risks, and provides advice on concomitant use. Given serious adverse reactions with multiple agents, patients should avoid taking over-the-counter medications or dietary supplements without prior consultation with a healthcare provider able to provide advice on the potential for interactions.
Time to Start PARNATE after Discontinuation of a Contraindicated Drug
For products that are contraindicated with PARNATE, a time period of 4 to 5 half-lives of the other product or any active metabolite should elapse before starting treatment with PARNATE. After stopping treatment with an MAO inhibitor antidepressant, a time period of at least 1 week or 4 to 5 half-lives of the other MAO inhibitor (whichever is longer) should elapse before starting treatment with PARNATE because of the risk for clinically significant adverse reactions after discontinuation due to persistent MAO inhibition [see Dosage and Administration (2.2), Warnings and Precautions (5.9) ]. This period can be several weeks long (e.g., a minimum of 5 weeks for fluoxetine given fluoxetine’s long half-life). Refer to the prescribing information of the contraindicated product for relevant information.
Time to Start Contraindicated Drug after Discontinuation of PARNATE
The potential for interactions persists after discontinuation of PARNATE until MAO activity has sufficiently recovered. Inhibition of MAO may persist up to 10 days following discontinuation [see Warnings and Precautions (5.9)]. After stopping PARNATE, at least 1 week should elapse before starting another MAOI (intended to treat MDD) or other contraindicated antidepressants. Refer to the prescribing information of any agent considered for subsequent use for recommendations on the duration of a waiting period after discontinuation of a MAO inhibitor.
If in the absence of therapeutic alternatives and emergency treatment with a contraindicated drug (e.g., linezolid, intravenous methylene blue, direct-acting sympathomimetic drugs such as epinephrine) becomes necessary and cannot be delayed, discontinue PARNATE as soon as possible before initiating treatment with the other agent, and monitor closely for adverse reactions.
Table 3 Clinically Significant Drug Interactions with Drug Classes*
Product | Clinical Comment on Concomitant Usea | Predominant Effect/Risk [Hypertensive Reaction (HR)b or Serotonin Syndrome (SS)c ] |
Agents with blood pressure-reducing effects | Use with cautiond | Hypotensione |
Non-selective H1 receptor antagonists | Contraindicateda | Increased anticholinergic effects |
Beta-adrenergic blockers (see also agents or procedures with blood pressure-reducing effects) | Use with the cautiond | More pronounced bradycardia, postural hypotensione |
Blood glucose-lowering agents | Dosage reduction of such agents may be necessary. Monitor blood glucose. | Excessive reduction of blood glucose (additive effect)f |
CNS depressant agents (including opioids, alcohol, sedatives, hypnotics) | Use with cautiond | Increased CNS depression |
Dietary supplements containing sympathomimetics | Contraindicateda | |
Antidepressants including but not limited to:
| Contraindicateda | SS for all antidepressants For MAOIs, increased MAO inhibition and risk of adverse reactions, SS, and HRg |
Amphetamines and methylphenidates and derivatives | Contraindicateda | HR |
Sympathomimetic drugs** | Contraindicateda | HR; Including risk of intracerebral hemorrhage |
Triptans | Contraindicateda | SS |
* Some drugs in these groups may also be listed in Table 4 below.
** Sympathomimetic drugs include amphetamines as well as cold, hay fever or weight-reducing products that contain vasoconstrictors such as pseudoephedrine, phenylephrine, and ephedrine)
a [See Contraindications (4.1)]; b [See Warnings and Precautions (5.2)]; c [See Warnings and Precautions (5.3)]
d If not otherwise specified in this table, consider avoiding concomitant use (see also information on medication-free intervals, use agent at the lowest appropriate dosage, monitor for effects of the interaction, advise the patient to report potential effects).
e [See Warnings and Precautions (5.5)]; f [See Warnings and Precautions (5.14)]; g [See Overdosage (10.1)] Table 4: Clinically Significant Drug Interactions with Individual Products*
Product | Clinical Comment on Concomitant Usea | Predominant Effect/Risk [Hypertensive Reaction (HR)b or Serotonin Syndrome (SS)c ] |
Altretamine | Use with cautiond | Orthostatic hypotensione |
Buspirone | Contraindicateda | HR |
Carbamazepine | Contraindicateda | SS |
Chlorpromazine | Use with cautiond | Hypotensive effectse |
Cyclobenzaprine | Contraindicateda | SS |
Dextromethorphan | Contraindicateda | SS; Psychosis, bizarre behavior |
Dopamine | Contraindicateda | HR |
Droperidol | Use with cautiond | QT interval prolongation |
Entacapone | Use with cautiond | HR |
Fentanyl | Use with cautiond | SS |
Hydroxytryptophan | Contraindicateda | SS |
Levodopa | Contraindicateda | HR |
Lithium | Use with cautiond | SS |
Meperidine | Contraindicateda | SS |
Methadone | Use with cautiond | SS |
Methyldopa | Contraindicateda | HR |
Metoclopramide | Use with cautiond | HR/SS |
Mirtazapine | Contraindicateda | SS |
Oxcarbazepine | Use with cautiond because of close structural relationship with tricyclic antidepressants | SS |
Rasagiline | Contraindicateda | HR |
Reserpine | Contraindicateda | HR |
S-adenosyl-L-methionine (SAM-e) | Contraindicateda | SS |
Tapentadol | Contraindicateda | HR/SS |
Tetrabenazine | Contraindicateda | HR |
Tolcapone | Use with cautiond | HR |
Tramadol | Use with cautiond | SS; Increased seizure risk |
Tryptophan | Contraindicateda | SS |
* Some drugs in this table may also belong to groups listed in Table 3 above, and may be associated with additional interactions.
a [See Contraindications (4.1)]; b [See Warnings and Precautions (5.3)]; c [See Warnings and Precautions (5.7)] d If not otherwise specified in this table, consider avoiding concomitant use (see also information on medication-free intervals , use agent at the lowest appropriate dose, monitor for effects of the interaction, advise the patient to report potential effects, and be prepared to discontinue the agent and treat effects of the interactione [See Warnings and Precautions (5.5)]
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