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  1. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or Promethazine HCl Concomitant Conditions and Other Risk Factors Avoid use of promethazine in patients at risk for respiratory depression Consider these risks when prescribing or dispensing promethazine HCl and codeine phosphate oral solution Promethazine HCl and codeine phosphate oral solution-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale Reserve promethazine HCl and codeine phosphate oral solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of

    Concomitant Conditions and Other Risk Factors Avoid use of promethazine in patients at risk for respiratory depression. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death.

    Consider these risks when prescribing or dispensing promethazine HCl and codeine phosphate oral solution. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed promethazine HCl and codeine phosphate oral solution.

    Management of respiratory depression includes discontinuation of promethazine HCl and codeine phosphate oral solution, close observation, supportive measures, and use of opioid antagonists e. Hi tech promethazine syrup Akorn Akorn, Inc.

    Reserve promethazine HCl and codeine phosphate oral solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an abilify coupon card assessment of the etiology of the cough has been made. This rapid conversion results in higher than expected serum morphine levels.

    Because of these risks, avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol [see Drug Interactions 7. Excessively large dosages of antihistamines, including promethazine hydrochloride, in pediatric patients may cause sudden death [see Overdosage 10 ].

    While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of promethazine HCl and codeine phosphate oral solution, the risk my source greatest during the initiation of therapy, when promethazine HCl and codeine phosphate oral solution is used concomitantly with other drugs that may cause respiratory depression [see Warnings and Precautions 5.

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    Akorn, Inc. Other factors besides those listed there could also adversely affect our results. Reserve promethazine HCl and codeine phosphate oral solution for use in adult generic for prednisolone acetate for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.

    Use of cytochrome P 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with promethazine HCl and codeine phosphate oral solution requires careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine.

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    Comment 邃1 about product

    Other factors besides those listed there could also adversely affect our results. If concomitant use of promethazine HCl and codeine phosphate oral solution with inhibitors and inducers of CYP3A4 is necessary, monitor patients for signs and symptoms that may reflect opioid toxicity and opioid withdrawal [see Drug Interactions 7.


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    Comment 邃2 about product

    Because of the risk of respiratory depression, avoid the use of opioid antitussives, including promethazine HCl and codeine phosphate oral solution in patients with compromised respiratory function, patients at risk of respiratory failure, and in elderly, cachectic, or debilitated patients.


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    Comment 邃3 about product

    Risk factors include conditions associated with hypoventilation, such as postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, and concomitant use of other medications that cause respiratory depression.


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    Comment 邃4 about product

    You can identify these statements by the fact that they do not relate strictly to historical or current facts. Because of the risk of life-threatening respiratory depression and death: Discontinuation of a concomitantly used cytochrome P 2D6 inhibitor may result in a decrease in codeine plasma concentration and an increase in active metabolite morphine plasma concentration which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression.


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    Comment 邃5 about product

    The addressable IMS market size figures presented in this press release outline the approximate aggregate size of the potential market and are not forecasts of our future sales. Advise patients to avoid engaging in hazardous tasks requiring mental alertness and motor coordination after ingestion of promethazine HCl and codeine phosphate oral solution.


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    Comment 邃6 about product

    About Akorn Akorn, Inc. To reduce the risk of overdose and respiratory depression, ensure that the dose of promethazine HCl, phenylephrine HCl and codeine phosphate oral solution is communicated clearly and dispensed accurately [see Dosage and Administration 2.


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