Dihydro CP Syrup
Name: Dihydro CP Syrup
DiHydro-CP Syrup
Antitussive/Antihistamine/Decongestant
Rx Only
CIII
DESCRIPTION
Each teaspoonful (5 mL) for oral administration contains:
Dihydrocodeine Bitartrate.....................................................7.5 mg
(WARNING-May be habit forming)
Chlorpheniramine Maleate.......................................................2 mg
Pseudoephedrine Hydrochloride.............................................15 mg
This product contains the following inactive ingredients:
Citric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.
Dihydrocodeine Bitartrate is an antitussive with the chemical name (Morphine-6-ol,4,5-epoxy-3-methoxy-17methyl-,(5α,6α)-2,3-dihydroxybutanedioate (1:1) (salt). It has the following structural formula:
Chlorpheniramine Maleate is an antihistamine having the chemical name 2-Pyridinepropanamine,γ-(4-chlorophenyl)-N,N-dimethyl-,(Z)-2-butenedioate (1:1). It has the following chemical structure:
Pseudoephedrine Hydrochloride is a decongestant having the chemical name, Benzenemethanol, α-[1-(methylamino) ethyl]-,[S-(R*R*)-, hydrochloride. It has the following structural formula:
Rx Only
CIII
DESCRIPTION
Each teaspoonful (5 mL) for oral administration contains:
Dihydrocodeine Bitartrate.....................................................7.5 mg
(WARNING-May be habit forming)
Chlorpheniramine Maleate.......................................................2 mg
Pseudoephedrine Hydrochloride.............................................15 mg
This product contains the following inactive ingredients:
Citric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.
Dihydrocodeine Bitartrate is an antitussive with the chemical name (Morphine-6-ol,4,5-epoxy-3-methoxy-17methyl-,(5α,6α)-2,3-dihydroxybutanedioate (1:1) (salt). It has the following structural formula:
Chlorpheniramine Maleate is an antihistamine having the chemical name 2-Pyridinepropanamine,γ-(4-chlorophenyl)-N,N-dimethyl-,(Z)-2-butenedioate (1:1). It has the following chemical structure:
Pseudoephedrine Hydrochloride is a decongestant having the chemical name, Benzenemethanol, α-[1-(methylamino) ethyl]-,[S-(R*R*)-, hydrochloride. It has the following structural formula:
Dihydro CP Syrup - Clinical Pharmacology
Dihydrocodeine is a semisynthetic narcotic analgesic antitussive related to codeine, with multiple actions qualitatively similar to those of codeine: the most prominent of these involve the central nervous system and organs with smooth muscle components.
Chlorpheniramine is an alkylamine type antihistamine. This group of antihistamines is among the most active histamine antagonists and is generally effective in relatively low doses. The drugs are not so prone to produce drowsiness and are therefore among the most suitable agents for daytime use, but a significant proportion of patients do experience this effect.
Pseudoephedrine Hydrochloride is a sympathomimetic amine, which acts predominately on alpha-receptors and has little action on beta-receptors. It therefore functions as an oral nasal decongestant with minimal CNS stimulation.
Chlorpheniramine is an alkylamine type antihistamine. This group of antihistamines is among the most active histamine antagonists and is generally effective in relatively low doses. The drugs are not so prone to produce drowsiness and are therefore among the most suitable agents for daytime use, but a significant proportion of patients do experience this effect.
Pseudoephedrine Hydrochloride is a sympathomimetic amine, which acts predominately on alpha-receptors and has little action on beta-receptors. It therefore functions as an oral nasal decongestant with minimal CNS stimulation.
Indications and Usage for Dihydro CP Syrup
This product is indicated for the temporary relief of cough and nasal congestion associated with upper respiratory tract infections and allergies.
Drug Abuse and Dependence
This combination product is subject to the provisions of the Controlled Substances Act and has been placed in Schedule III. Dihydrocodeine can produce drug dependence of the codeine type and therefore has the potential of being abused. Psychological dependence, physical dependence, and tolerance may develop upon repeat administration of dihydrocodeine, and it should be prescribed and administered with the same degree of caution appropriate to the use of other opioid medications. Symptoms of dihydrocodeine withdrawal consist of irritability, restlessness, insomnia, diaphoresis, anxiety, and palpitations.
Overdosage
An overdose of this product is a potentially lethal overdose situation, and consultation with a regional Poison Control Center is recommended. A listing of the Poison Control Center can be found in a standard reference such as the Physician's Desk Reference.
Signs and Symptoms: Symptoms of an overdose include pinpoint pupils, respiratory depression, extreme somnolence progressing to stupor, loss of consciousness or coma, skeletal muscle flaccidity, cold and clammy skin and other symptoms common with narcotic overdosage. Convulsions, cardiovascular collapse, and death may occur. A single case of acute rhabdomyolysis associated with an overdose of dihydrocodeine has been reported.
Recommended Treatment:
Immediate treatment of an overdose of this product includes support of cardiovascular function and measures to reduce further drug absorption. Vomiting should be induced with syrup of ipecac. If the patient is alert and has adequate laryngeal reflexes, oral activated charcoal should follow. The first dose should be accompanied by an appropriate cathartic. Gastric lavage may be necessary. Hypotension is usually hypovolemic and should be treated with fluids.
Endotracheal intubation and artificial respiration may be necessary. The pure opioid antagonist naloxone or nalmexone is a specific antidote against respiratory depression that results from opioid overdose. Opioid antagonists should be given in the absence of clinically significant respiratory or circulatory depression secondary to opioid overdose. They should be administered cautiously to persons who are known, or suspected to be, physically dependent on any opioid agonist including dihydrocodeine. In such cases, an abrupt or complete reversal of opiod effects may precipitate an acute abstinence syndrome. The prescribing information for the specific opioid antagonist should be consulted for details of there proper use.
Signs and Symptoms: Symptoms of an overdose include pinpoint pupils, respiratory depression, extreme somnolence progressing to stupor, loss of consciousness or coma, skeletal muscle flaccidity, cold and clammy skin and other symptoms common with narcotic overdosage. Convulsions, cardiovascular collapse, and death may occur. A single case of acute rhabdomyolysis associated with an overdose of dihydrocodeine has been reported.
Recommended Treatment:
Immediate treatment of an overdose of this product includes support of cardiovascular function and measures to reduce further drug absorption. Vomiting should be induced with syrup of ipecac. If the patient is alert and has adequate laryngeal reflexes, oral activated charcoal should follow. The first dose should be accompanied by an appropriate cathartic. Gastric lavage may be necessary. Hypotension is usually hypovolemic and should be treated with fluids.
Endotracheal intubation and artificial respiration may be necessary. The pure opioid antagonist naloxone or nalmexone is a specific antidote against respiratory depression that results from opioid overdose. Opioid antagonists should be given in the absence of clinically significant respiratory or circulatory depression secondary to opioid overdose. They should be administered cautiously to persons who are known, or suspected to be, physically dependent on any opioid agonist including dihydrocodeine. In such cases, an abrupt or complete reversal of opiod effects may precipitate an acute abstinence syndrome. The prescribing information for the specific opioid antagonist should be consulted for details of there proper use.
Product packaging
The packaging below represents the labeling currently used:
Principal Display Panel and Side Panel for 473 mL label:
NDC 60258-760-16
DiHydro-CP Syrup
Antitussive/Antihistamine/Decongestant
Each teaspoonful (5 mL) for oral administration contains:
Dihydrocodeine Bitartrate..................................................7.5 mg
(WARNING: May be habit forming)
Chlorpheniramine Maleate....................................................2 mg
Pseudoephedrine HCl.........................................................15 mg
SUGAR FREE/ALCOHOL FREE/DYE FREE
Rx Only
CYPRESS PHARMACEUTICALS, INC.
16 fl oz (473 mL)
USUAL DOSAGE: Adults and children 12 years of age and over: 1 to 2 teaspoonfuls
(5 mL to 10 mL), every 4 to 6 hours as needed. Children 6 to under 12 years of age:
1/2 to 1 teaspoonful (2.5 mL to 5 mL), every 4 to 6 hours as needed.
Children under 6 years of age: as directed by a physician.
Not recommended for children under 2 years of age.
For full prescribing information see attached insert.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE
OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Store at controlled room temperature, 15°-30°C(59°-86°F).
Dispense in a tight,light-resistant container as defined in the USP/NF with a child-resistant closure.
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
This container is not to be dispensed to the consumer.
Manufactured for: Cypress Pharmaceutical, Inc., Madison, MS 39110
PSL051616 Rev. 01/10
Revised: 05/2010 Cypress Pharmaceutical, Inc.
Principal Display Panel and Side Panel for 473 mL label:
NDC 60258-760-16
DiHydro-CP Syrup
Antitussive/Antihistamine/Decongestant
Each teaspoonful (5 mL) for oral administration contains:
Dihydrocodeine Bitartrate..................................................7.5 mg
(WARNING: May be habit forming)
Chlorpheniramine Maleate....................................................2 mg
Pseudoephedrine HCl.........................................................15 mg
SUGAR FREE/ALCOHOL FREE/DYE FREE
Rx Only
CYPRESS PHARMACEUTICALS, INC.
16 fl oz (473 mL)
USUAL DOSAGE: Adults and children 12 years of age and over: 1 to 2 teaspoonfuls
(5 mL to 10 mL), every 4 to 6 hours as needed. Children 6 to under 12 years of age:
1/2 to 1 teaspoonful (2.5 mL to 5 mL), every 4 to 6 hours as needed.
Children under 6 years of age: as directed by a physician.
Not recommended for children under 2 years of age.
For full prescribing information see attached insert.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE
OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Store at controlled room temperature, 15°-30°C(59°-86°F).
Dispense in a tight,light-resistant container as defined in the USP/NF with a child-resistant closure.
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
This container is not to be dispensed to the consumer.
Manufactured for: Cypress Pharmaceutical, Inc., Madison, MS 39110
PSL051616 Rev. 01/10
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| Labeler - Cypress Pharmaceutical, Inc. (790248942) |