Wockhardt Promethazine Codeine Cough Syrup

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General information about the safe and effective use of wockhardt cough syrupSolution.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use wockhardt w/ codeine cough syrupfor a condition for which it was not prescribed. Do not give wockhardt w/ codeine cough syrup to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about wockhardt w/ codeine cough syrup that is written for health professionals.

What are the ingredients in wockhardt w/ codeine cough syrup?

Active ingredients: promethazine hydrochloride and codeine phosphate

Inactive ingredients: Artificial raspberry flavor, ascorbic acid, citric acid anhydrous, D&C Red #33, dehydrated alcohol, edetate disodium, FD&C Blue #1, glycerin, liquid sugar, methylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate and sodium propionate.

 

Each 5 mL (one teaspoonful), for oral administration contains: Promethazine hydrochloride 6.25 mg; codeine phosphate 10 mg in a flavored oral solution base with a pH between 4.7 and 5.2. Alcohol 7%.

Inactive Ingredients: Artificial raspberry flavor, ascorbic acid, citric acid anhydrous, D&C Red #33, dehydrated alcohol, edetate disodium, FD&C Blue #1, glycerin, liquid sugar, methylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate and sodium propionate.

Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy; it is classified pharmacologically as a narcotic analgesic. Codeine phosphate may be chemically designated as 7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate.

The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. It has a molecular weight of 406.37, a molecular formula of C18H21NO3•H3PO4•½H2O, and the following structural formula:

WARNING: ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

A quick information about wockhardt cough syrup can be seen on the table below

Generic Name	Promethazine with Codeine Cough Syrup CV
Strength	6.25/10mg per 5mL
Description	Clear purple syrup with raspberry flavor
FDA Rating	AA
Compares To	Phenergan® w/Codeine
Therapeutic Category:	Antihistamine/Antitussive
Product line:	Morton Grove
Imprint Code:	n/a
Prescribing Information:	Below
ANDA #:	88-875

Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children

Life-threatening respiratory depression and death have occurred in children who received codeine. Most of the reported cases occurred following tonsillectomy and/or adenoidectomy, and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism.  Promethazine HCl and Codeine Phosphate Oral Solution is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (see CONTRAINDICATIONS). Avoid the use of Promethazine HCl and Codeine Phosphate Oral Solution in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine. (See WARNINGS – ULTRA-RAPID METABOLISM OF CODEINE AND RESPIRATORY DEPRESSION).

Promethazine and Respiratory Depression in Children

Postmarketing cases of respiratory depression, including fatalities have been reported with use of promethazine in pediatric patients. Children may be particularly sensitive to the additive respiratory depressant effects when promethazine is combined with other respiratory depressants, including codeine. (See WARNINGS – PROMETHAZINE AND RESPIRATORY DEPRESSION IN CHILDREN).

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death (see WARNINGS, PRECAUTIONS – DRUG INTERACTIONS). Avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol

Promethazine HCl and Codeine Phosphate Oral Solution is contraindicated in all children younger than 12 years of age. (See WARNINGS – ULTRA- RAPID METABOLISM OF CODEINE AND RESPIRATORY DEPRESSION).

Promethazine HCl and Codeine Phosphate Oral Solution is contraindicated for postoperative management in children younger than 18 years who have undergone tonsillectomy and/or adenoidectomy. (See WARNINGS – ULTRA- RAPID METABOLISM OF CODEINE AND RESPIRATORY DEPRESSION).

Codeine is contraindicated in patients with a known hypersensitivity to the drug.

Promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines.

Antihistamines and codeine are both contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma

wockhardt w/ codeine cough syrup is contraindicated in all children younger than 12 years of age. (See WARNINGS – ULTRA- RAPID METABOLISM OF CODEINE AND RESPIRATORY DEPRESSION).

Promethazine HCl and Codeine Phosphate Oral Solution is contraindicated for postoperative management in children younger than 18 years who have undergone tonsillectomy and/or adenoidectomy. (See WARNINGS – ULTRA- RAPID METABOLISM OF CODEINE AND RESPIRATORY DEPRESSION).

Codeine is contraindicated in patients with a known hypersensitivity to the drug.

Promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines.

Antihistamines and codeine are both contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma

Promethazine (proe METH a zeen) with Codeine (KOE deen) Oral Solution, CV

(Promethazine Hydrochloride and Codeine Phosphate Oral Solution)

What is the most important information I should know about wockhardt w/ codeine cough syrup?

• Promethazine Hydrochloride and Codeine Phosphate Oral Solution can cause children to stop breathing (respiratory depression) and cause death.
  • Do not give wockhardt w/ codeine cough syrup to children younger than 12 years of age, or to children younger than 18 years of age after tonsillectomy or adenoidectomy surgery.
  • You should not give wockhardt w/ codeine cough syrup to children between 12 to 18 years of age who have certain risk factors for breathing problems, including:
    • recent surgery
    • obstructive sleep apnea
    • are obese
    • severe lung problems
    • other medical conditions that can cause difficulty breathing, such as neuromuscular problems
    • taking other medicines that cause breathing problems
• You should not breastfeed during treatment with wockhardt w/ codeine cough syrup because it may cause your child to stop breathing and cause death.
• Severe drowsiness, breathing problems (respiratory depression), coma, and death can happen in adults and children who take wockhardt w/ codeine cough syrup with benzodiazepines, or other central nervous system depressants, including alcohol.
  • Avoid taking other medicines that can cause drowsiness or sleepiness, or drinking alcohol during treatment with wockhardt w/ codeine cough syrup. Ask your healthcare provider for a list of these medicines if you are not sure.
• Promethazine Hydrochloride and Codeine Phosphate Oral Solution can cause breathing problems (respiratory depression) and drowsiness.
  • Take wockhardt w/ codeine cough syrup exactly as prescribed by your healthcare provider. If you take the wrong dose of Promethazine Hydrochloride and Codeine Phosphate Oral Solution you could overdose and die. See the Medication Guide section called “How should I take wockhardt w/ codeine cough syrup?” for important information about how to take wockhardt w/ codeine cough syrup correctly.
  • Avoid driving a car or operating machinery during treatment with Promethazine Hydrochloride and Codeine Phosphate Oral Solution.
• Call your healthcare provider or get emergency medical help right away if anyone taking Promethazine Hydrochloride and Codeine Phosphate Oral Solution, or your breastfeeding baby has any of the symptoms below:
  • increased sleepiness
  • confusion
  • difficulty breathing
  • shallow breathing
  • limpness
  • your baby has difficulty breastfeeding
• Keep Promethazine Hydrochloride and Codeine Phosphate Oral Solution in a safe place away from children. Accidental use by a child is a medical emergency and can cause death. If a child accidentally takes Promethazine Hydrochloride and Codeine Phosphate Oral Solution, get emergency medical help right away.

What is wockhardt w/ codeine cough syrup?

• Wockhardt w/ codeine cough syrup is a prescription medicine used to temporarily treat cough and upper respiratory symptoms, including a stuffy nose (nasal congestion) that you can have with allergies or a common coldwockhardt w/ codeine cough syrup contains 2 medicines, promethazine and codeine.  Promethazine is an antihistamine. Codeine is a narcotic cough suppressant.
• Wockhardt w/ codeine cough syrup is a federal controlled substance (C-V) because it contains codeine that can be abused or lead to dependence. Keep Promethazine Hydrochloride and Codeine Phosphate Oral Solution in a safe place to prevent misuse and abuse. Selling or giving away wockhardt w/ codeine cough syrup may harm others, and is against the law. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs
• Promethazine Hydrochloride and Codeine Phosphate Oral Solution is not for children under 12 years of age.

Who should not take wockhardt w/ codeine cough syrup Oral Solution?

• Do not give Promethazine Hydrochloride and Codeine Phosphate Oral Solution to children younger than 12 years of age.
• Do not give wockhardt w/ codeine cough syrup Oral Solution to children younger than 18 years of any age after tonsillectomy or adenoidectomy surgery.
• Do not take Promethazine Hydrochloride and Codeine Phosphate Oral Solution if you are allergic to any of the ingredients in Promethazine Hydrochloride and Codeine Phosphate Oral Solution. See the end of this Medication Guide for a complete list of ingredients in wockhardt w/ codeine cough syrup.
• Do not take wockhardt w/ codeine cough syrup if you have asthma.
• Do not take wockhardt w/ codeine cough syrup Oral Solution if you have high blood pressure or narrowing of blood vessels to your legs or arms (peripheral vascular insufficiency).
• Do not take Promethazine Hydrochloride and Codeine Phosphate Oral Solution if you take a medicine called a Monoamine Oxidase Inhibitor (MAOI).

Before you take wockhardt w/ codeine cough syrup Oral Solution, tell your healthcare provider about all of your medical conditions, including if you:

• have a drug dependence
• have lung or breathing problems including chronic obstructive pulmonary disease (COPD), or sleep apnea.
• have had a head injury
• have pain in your stomach-area (abdomen)
• have a history of severe or persistent cough
• have prostate problems
• have problems with your urinary tract (urethral stricture) or difficulty urinating
• have had surgery recently or plan to have surgery
• drink alcohol
• have kidney or liver problems
• have thyroid problems including hypothyroidism
• have Addison’s disease
• have glaucoma (increased pressure in eyes)
• have diabetes
• have seizures
• have heart problems or blood vessel (cardiovascular) problems including high blood pressure or peripheral vascular insufficiency See “WHO SHOULD NOT TAKE PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE ORAL SOLUTION?
• have blood disorders including low white blood cells
• are pregnant or plan to become pregnant. It is not known if wockhardt w/ codeine cough syrup Oral Solution will harm your unborn baby. You and your healthcare provider should decide if you should take wockhardt w/ codeine cough syrup Oral Solution while you are pregnant.
• are breastfeeding or plan to breastfeed. Codeine Phosphate passes into your breast milk and may harm your baby. It is not known if Promethazine Hydrochloride can pass into your breast milk. You should not breastfeed during treatment with wockhardt w/ codeine cough syrup Oral Solution.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking wockhardt w/ codeine cough syrup Oral Solution with certain other medicines can cause side effects or affect how well wockhardt w/ codeine cough syrup Oral Solution or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider. Especially tell your healthcare provider if you:

• take pain medicines such as narcotics
• take cold or allergy medicines that contain antihistamines or cough suppressants
• take medicines for mental illness (anti-psychotics, anti-anxiety)
• drink alcohol
• take medicines for depression, including monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants (TCAs)
• take medicines for stomach or intestinal problems
• take ergot containing medicines
• take medicines called alpha blockers
• take medicines called beta blockers
• take stimulants or uppers (amphetamines)

Ask your healthcare provider if you are not sure if you take one of these medicines.

How should I take wockhardt w/ codeine cough syrup Oral Solution?

• Take wockhardt w/ codeine cough syrup Oral Solution exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how much Promethazine Hydrochloride and Codeine Phosphate Oral Solution to take and when to take it. Do not change your dose without talking to your healthcare provider.
• Ask your pharmacist to give you a measuring device to help you measure the correct amount of Promethazine Hydrochloride and Codeine Phosphate Oral Solution. Do not use a household teaspoon to measure your medicine. You may accidently take too much.
• Do not take more than 30 mL of Promethazine Hydrochloride and Codeine Phosphate Oral Solution in 24 hours.
• If you take too much wockhardt w/ codeine cough syrup, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking Promethazine Hydrochloride and Codeine Phosphate Oral Solution?

• Promethazine Hydrochloride and Codeine Phosphate Oral Solution can cause you to be drowsy. Avoid driving a car or operating machinery during the treatment with Promethazine Hydrochloride and Codeine Phosphate Oral Solution. Also, watch your child closely when riding a bike.
• Avoid drinking alcohol during the treatment with Promethazine Hydrochloride and Codeine Phosphate Oral Solution. Drinking alcohol can increase your chances of having serious side effects.
• Avoid spending a long time in sunlight.

What are the possible side effects of  wockhardt w/ codein cough syrup Oral Solution?

• See “WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE ORAL SOLUTION?”
• Breathing problems (respiratory depression) which can lead to death. Call your healthcare provider or get emergency treatment right away if you have excessive sleepiness, shallow or slow breathing, or confusion.
• Physical dependence or abuse. Take Promethazine Hydrochloride and Codeine Phosphate Oral Solution exactly as your healthcare provider tells you to take it. Stopping Promethazine Hydrochloride and Codeine Phosphate Oral Solution suddenly could cause withdrawal symptoms.
• Bowel problems including constipation or stomach pain.
• Increased intracranial pressure.
• Feeling dizzy, faint or light-headed, especially when you stand up (orthostatic hypotension) . Light-headedness or fainting may happen when getting up too quickly from a sitting or lying position.
• Neuroleptic malignant syndrome (NMS) which can lead to death. Tell you healthcare provider right away if you have any of the following symptoms of NMS:
  • high fever
  • stiff muscles
  • confusion
  • sweating
  • changes in pulse, heart rate, and blood pressure

The most common side effects of wockhardt codeine cough syrup  Oral Solution include:

• sleepiness
• confusion
• dryness of mouth, nose, throat
• nausea and vomiting
• difficulty urinating
• trouble breathing
• high blood pressure
• restlessness
• fast heart beat

These are not all the possible side effects of wockhardt cough syrup Oral Solution. Call your doctor for medical advice about side effects.

How should I store wockhardt cough syrup Oral Solution?

• Store Promethazine Hydrochloride and Codeine Phosphate Oral Solution at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep wockhardt cough syrup and Codeine Phosphate Oral Solution in a tightly closed, child-resistant container and out of the light.
• Safely throw away medicine that is out of date or no longer needed.
• Keep wockhardt cough syrup and Codeine Phosphate Oral Solution and all medicines out of the reach of children.

This Medication Guide has been approved by the U.S. Food and Drug Administration.