New Step by Step Map For akorn codeine
5.18 Significant Hypotension Promethazine HCl and codeine phosphate oral Resolution could lead to significant hypotension including orthostatic hypotension and syncope in ambulatory individuals. There exists enhanced chance in people whose skill to take care of hypertension has currently been compromised by a lowered blood quantity or concurrent administration of particular CNS depressant medicine (e.Discontinuation of the concomitantly used cytochrome P450 2D6 inhibitor may result in a reduce in codeine plasma concentration and a rise in Energetic metabolite morphine plasma concentration which could enhance or prolong adverse reactions and should lead to most likely fatal respiratory despair.
five.17 Bone-Marrow Despair Promethazine HCl and codeine phosphate oral solution really should be used with warning in people with bone-marrow melancholy. Leukopenia and agranulocytosis are already documented, usually when promethazine has become used in Affiliation with other acknowledged marrow-poisonous brokers.
Asthma together with other Pulmonary Sickness The use of promethazine HCl and codeine phosphate oral solution in people with acute or severe bronchial asthma in an unmonitored environment or from the absence of resuscitative gear is contraindicated [see Contraindications (4)]. Opioid analgesics and antitussives, together with codeine, one of several Energetic components in promethazine HCl and codeine phosphate oral solution, should not be Employed in sufferers with acute febrile ailment associated with productive cough or in people with Continual respiratory disorder where by interference with power to crystal clear the tracheobronchial tree of secretions would have a deleterious impact on the affected person’s respiratory purpose.
Due to the potential for promethazine to reverse epinephrine’s vasopressor influence, epinephrine really should not be used to take care of hypotension related to promethazine overdose.
Here’s what you need to know about which medicine and items are now being recalled and how to proceed Should your medication is more info one of them, In keeping with authorities.
Use warning When contemplating the use of promethazine HCl and codeine phosphate oral Remedy in sufferers 65 years of age or more mature.
Parenteral drug abuse is commonly linked to transmission of infectious diseases for instance hepatitis and HIV.
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Notify people that a house teaspoon is not really an accurate measuring unit and these use could lead on to overdosage and severe adverse reactions [see Overdosage (ten)]. For prescriptions exactly where a measuring unit will not be delivered, a pharmacist can offer an correct calibrated measuring machine and can provide Guidelines for measuring the correct dose.
Steer clear of the usage of promethazine HCl and codeine phosphate oral Resolution in people who will be getting inhibitors of CYP2D6.
Prevent the usage of promethazine HCl and codeine phosphate oral Remedy in sufferers who're taking CYP3A4 inducers. If concomitant usage of a CYP3A4 inducer is critical, follow the affected individual for lessened efficacy.
e., various copies in the gene for cytochrome P450 isoenzyme 2D6 or significant morphine concentrations). Small children with rest apnea might be significantly sensitive on the respiratory depressant outcomes of codeine.