Drug Interactions between Donatussin Drops and safinamide
This report displays the potential drug interactions for the following 2 drugs:
- Donatussin Drops (guaifenesin/phenylephrine)
- safinamide
Interactions between your drugs
phenylephrine safinamide
Applies to: Donatussin Drops (guaifenesin / phenylephrine) and safinamide
MONITOR: Monoamine oxidase inhibitors (MAOIs) may theoretically potentiate the cardiovascular effects of sympathomimetic agents following oral and/or topical administration (e.g., nasal decongestants, ophthalmic vasoconstrictors) by inhibiting the breakdown of catecholamines. There have been occasional reports of increased blood pressure and heart rate in patients receiving systemic direct-acting agents and MAOIs. One case of hypertensive crisis has been reported in a patient taking ephedrine with the recommended dosage of a selective MAO-B inhibitor. Most topical decongestants and vasoconstrictors are direct-acting sympathomimetics, which appear to be less affected by MAOIs than indirect- or mixed-acting sympathomimetics such as pseudoephedrine or ephedrine. No increase in blood pressure or heart rate was observed when tranylcypromine was administered to a patient using 1% epinephrine eye drop twice a day. However, during the postmarketing period, elevated blood pressure was reported in a patient using ophthalmic tetrahydrozoline drops while taking the recommended dosage of rasagiline, another selective MAO-B inhibitor. While MAOI use has been reported to precipitate severe hypertensive reactions and hyperpyrexia in patients receiving indirect- or mixed-acting agents, most studies have found minimal effect on pressor response to systemically administered direct-acting agents including epinephrine, norepinephrine, and isoprenaline. Nevertheless, increased pressor effects and greater than 50% reductions in the required dosage of direct-acting agents have been reported in hypertensive patients who were being treated for MAOI-induced postural hypotension.
MANAGEMENT: Caution and more frequent blood pressure monitoring may be advisable when oral and/or topical sympathomimetic agents are coadministered with MAOIs including safinamide.
References
- Smookler S, Barmudez AJ (1982) "Hypertensive crisis resulting from an MAO inhibitor and an over-the counter appetite suppressant." Ann Emerg Med, 11, p. 482-4
- Pettinger WA, Soyangco FG, Oates JA (1968) "Inhibition of monoamine oxidase in man by furazolidone." Clin Pharmacol Ther, 9, p. 442-7
- Schulz R, Antonin KH, Hoffmann E, et al. (1989) "Tyramine kinetics and pressor sensitivity during monoamine oxidase inhibition by selegiline." Clin Pharmacol Ther, 46, p. 528-36
- Elis J, Laurence DR, Mattie H, Prichard BN (1967) "Modification by monoamine oxidase inhibitors of the effect of some sympathomimetics on blood pressure." Br Med J, 2, p. 75-8
- Goldberg LI (1964) "Monoamine oxidase inhibitors: adverse reactions and possible mechanisms." JAMA, 190, p. 456-62
- Wright SP (1978) "Hazards with monoamine-oxidase inhibitors: a persistent problem." Lancet, 1, p. 284-5
- Boakes AJ, Laurence DR, Teoh PC, Barar FS, Benedikter LT, Pritchard BN (1973) "Interactions between sympathomimetic amines and antidepressant agents in man." Br Med J, 1, p. 311-5
- Goulet JP, Perusse R, Turcotte JY (1992) "Contraindications to vasoconstrictors in dentistry: Part III. Pharmacologic interactions." Oral Surg Oral Med Oral Pathol, 74, p. 692-7
- Sjoerdsma A (1966) "Catecholamine-drug interactions in man." Pharmacol Rev, 18, p. 673-83
- Ban TA (1975) "Drug interactions with psychoactive drugs." Dis Nerv Syst, 36, p. 164-6
- Darcy PF, Griffin JP (1995) "Interactions with drugs used in the treatment of depressive illness." Adverse Drug React Toxicol Rev, 14, p. 211-31
- De Vita VT, Hahn MA, Oliverio VT (1965) "Monoamine oxidase inhibition by a new carcinostatic agent, n-isopropyl-a-(2-methylhydrazino)-p-toluamide (MIH). (30590)." Proc Soc Exp Biol Med, 120, p. 561-5
- Cusson JR, Goldenberg E, Larochelle P (1991) "Effect of a novel monoamine-oxidase inhibitor, moclobemide on the sensitivity to intravenous tyramine and norepinephrine in humans." J Clin Pharmacol, 31, p. 462-7
- Thompson DS, Sweet RA, Marzula K, Peredes JC (1997) "Lack of interaction of monoamine oxidase inhibitors and epinephrine in an older patient." J Clin Psychopharmacol, 17, p. 322-3
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- Cerner Multum, Inc. "Australian Product Information."
- Fenwick MJ, Muwanga CL (2000) "Anaphylaxis and monoamine oxidase inhibitors--the use of adrenaline." J Accid Emerg Med, 17, p. 143-4
- Agencia EspaƱola de Medicamentos y Productos Sanitarios Healthcare (2008) Centro de informaciĆ³n online de medicamentos de la AEMPS - CIMA. https://cima.aemps.es/cima/publico/home.html
- (2017) "Product Information. Xadago (safinamide)." US WorldMeds LLC
Drug and food interactions
safinamide food
Applies to: safinamide
GENERALLY AVOID: Foods that contain large amounts of tyramine may precipitate a hypertensive crisis in patients treated with safinamide. The proposed mechanism involves potentiation of the tyramine pressor effect due to inhibition of monoamine oxidase (MAO) by safinamide. Monoamine oxidase in the gastrointestinal tract and liver, primarily type A (MAO-A), is the enzyme responsible for metabolizing exogenous amines such as tyramine and preventing them from being absorbed intact. Once absorbed, tyramine is metabolized to octopamine, a substance that is believed to displace norepinephrine from storage granules causing a rise in blood pressure. In vitro, safinamide inhibits MAO-B with greater than 1000-fold selectivity over MAO-A, and neither safinamide nor its major metabolites inhibit MAO-A at clinically relevant concentrations. Results from an oral tyramine challenge study also suggest that safinamide is a selective inhibitor of MAO-B at the recommended dosages of 50 or 100 mg/day. However, this selectivity is not absolute and may diminish in a dose-related manner above the maximum recommended daily dosage. In clinical trials, the incidence of hypertension was 7% and 5% for safinamide 50 mg and 100 mg, respectively, versus 4% for placebo. There were no reported cases of hypertensive crisis.
Administration of safinamide following intake of a high-fat, high-caloric breakfast resulted in a slight delay in the absorption of safinamide, but had no effects on safinamide peak plasma concentration (Cmax) and systemic exposure (AUC) compared to administration under fasted conditions.
MANAGEMENT: Dietary restriction is not ordinarily required during safinamide treatment with respect to most foods and beverages that contain tyramine, which usually include aged, fermented, cured, smoked, or pickled foods (e.g., air-dried and fermented meats or fish, aged cheeses, most soybean products, yeast extracts, red wine, beer, sauerkraut). However, certain foods like some of the aged cheeses (e.g., Boursault, Liederkrantz, Mycella, Stilton) and pickled herring may contain very high amounts of tyramine and could potentially cause a hypertensive reaction in patients taking safinamide, even at recommended dosages, due to increased sensitivity to tyramine. Patients should be advised to avoid the intake of very high levels of tyramine (e.g., greater than 150 mg) and to promptly seek medical attention if they experience potential signs and symptoms of a hypertensive crisis such as severe headache, visual disturbances, confusion, stupor, seizures, chest pain, unexplained nausea or vomiting, and stroke-like symptoms. Blood pressure should be regularly monitored and managed accordingly. Medication adjustment may be necessary if blood pressure elevations are sustained or not adequately controlled. Safinamide should not be used at dosages exceeding 100 mg/day, or 50 mg/day in patients with moderate hepatic impairment (Child-Pugh B, 7-9), as it may increase the risk of hypertensive crisis and other adverse reactions associated with nonselective inhibition of MAO. Safinamide can be administered with or without food.
References
- (2023) "Product Information. Xadago (safinamide)." US WorldMeds LLC
- (2020) "Product Information. Onstryv (safinamide)." Valeo Pharma Inc
- (2022) "Product Information. Xadago (safinamide)." Seqirus Pty Ltd
- (2021) "Product Information. Xadago (safinamide)." Zambon UK Ltd
phenylephrine food
Applies to: Donatussin Drops (guaifenesin / phenylephrine)
MONITOR: Coadministration of two or more sympathomimetic agents may increase the risk of adverse effects such as nervousness, irritability, and increased heart rate. Central nervous system (CNS) stimulants, particularly amphetamines, can potentiate the adrenergic response to vasopressors and other sympathomimetic agents. Additive increases in blood pressure and heart rate may occur due to enhanced peripheral sympathetic activity.
MANAGEMENT: Caution is advised if two or more sympathomimetic agents are coadministered. Pulse and blood pressure should be closely monitored.
References
- Rosenblatt JE, Lake CR, van Kammen DP, Ziegler MG, Bunney WE Jr (1979) "Interactions of amphetamine, pimozide, and lithium on plasma norepineophrine and dopamine-beta-hydroxylase in schizophrenic patients." Psychiatry Res, 1, p. 45-52
- Cavanaugh JH, Griffith JD, Oates JA (1970) "Effect of amphetamine on the pressor response to tyramine: formation of p-hydroxynorephedrine from amphetamine in man." Clin Pharmacol Ther, 11, p. 656
- (2001) "Product Information. Adderall (amphetamine-dextroamphetamine)." Shire Richwood Pharmaceutical Company Inc
- (2001) "Product Information. Tenuate (diethylpropion)." Aventis Pharmaceuticals
- (2001) "Product Information. Sanorex (mazindol)." Novartis Pharmaceuticals
- (2001) "Product Information. Focalin (dexmethylphenidate)." Mikart Inc
- (2002) "Product Information. Strattera (atomoxetine)." Lilly, Eli and Company
Therapeutic duplication warnings
No warnings were found for your selected drugs.
Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.
See also
Drug Interaction Classification
Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit. | |
Moderately clinically significant. Usually avoid combinations; use it only under special circumstances. | |
Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan. | |
No interaction information available. |
Further information
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