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Category
Decongestant, nasal (systemic)—
Indications
Congestion, nasal (treatment), Congestion, sinus (treatment) or Congestion, eustachian tube (treatment)—Pseudoephedrine is indicated for temporary relief of congestion associated with acute coryza, acute eustachian salpingitis, serous otitis media with eustachian tube congestion, vasomotor rhinitis , and aerotitis (barotitis) media. Pseudoephedrine also may be indicated as an adjunct to analgesics, antihistamines, antibiotics, antitussives, or expectorants for optimum results in allergic rhinitis , croup, acute and subacute sinusitis, acute otitis media, and acute tracheobronchitis.
Mechanism of action
Pseudoephedrine acts on alpha-adrenergic receptors in the mucosa of the respiratory tract, producing vasoconstriction. The medication shrinks swollen nasal mucous membranes; reduces tissue hyperemia, edema, and nasal congestion; and increases nasal airway patency. Also, drainage of sinus secretions may be increased and obstructed eustachian ostia may be opened.
Biotransformation
Pseudoephedrine is incompletely metabolized in the liver.
Onset of action
15 to 30 minutes.
Time to peak effect
Within 30 to 60 minutes.
Duration of action
Tablets, oral solution, and syrup—3 to 4 hours.
Extended-release capsules and tablets—8 to 12 hours.
Elimination
Renal. About 55 to 75% of a dose is excreted unchanged. The rate of excretion is accelerated in acidic urine.
Precautions to Consider
Patients sensitive to other sympathomimetics (for example, albuterol, amphetamines, ephedrine, epinephrine, isoproterenol, metaproterenol, norepinephrine, phenylephrine, phenylpropanolamine, terbutaline) may be sensitive to this medication also.
Pregnancy/Reproduction
Pregnancy—
Studies in humans have not been done.
Studies in animals have not shown that pseudoephedrine causes teratogenic effects in the fetus. However, pseudoephedrine reduced average weight, length, and rate of skeletal ossification in the animal fetus.
Breast-feeding
Pseudoephedrine is distributed into breast milk; use by nursing mothers is not recommended, because of the higher than usual risk to infants, especially newborn and premature infants, of side effects from sympathomimetic amines. {32}
Pediatrics
Pseudoephedrine should be used with caution in infants, especially newborn and premature infants, because of the higher than usual risk of side/adverse effects.
Geriatrics
No information is available on the relationship of age to the effects of pseudoephedrine in geriatric patients. However, elderly patients are more likely to have age-related prostatic hypertrophy, which may require adjustment of dosage in patients receiving pseudoephedrine.
Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):
Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.
Anesthetics, hydrocarbon inhalation, such as:
Chloroform
Cyclopropane
Enflurane
Halothane
Isoflurane
Methoxyflurane
Trichloroethylene (administration of pseudoephedrine prior to or shortly after anesthesia with chloroform, cyclopropane, halothane, or trichloroethylene may increase the risk of severe ventricular arrhythmias, especially in patients with pre-existing heart disease, because these anesthetics greatly sensitize the myocardium to the effects of sympathomimetics)
(enflurane, isoflurane, or methoxyflurane may also cause some sensitization of the myocardium to the effects of sympathomimetics; caution is recommended in patients taking pseudoephedrine)
Antihypertensives or Diuretics used as antihypertensives (antihypertensive effects may be reduced when these medications are used concurrently with pseudoephedrine; the patient should be monitored carefully to confirm that the desired effect is being obtained
Beta-adrenergic blocking agents (concurrent use with pseudoephedrine may inhibit the therapeutic effect of these medications; beta-blockade may result in unopposed alpha-adrenergic activity of pseudoephedrine, with a risk of hypertension and excessive bradycardia and possible heart block
Central nervous system (CNS) stimulation–producing medications, other (concurrent use with pseudoephedrine may result in additive CNS stimulation to excessive levels, which may cause unwanted effects such as nervousness, irritability, insomnia, or possibly convulsions or cardiac arrhythmias; close observation is recommended)
Citrates (concurrent use may inhibit urinary excretion and prolong the duration of action of pseudoephedrine)
Cocaine, mucosal-local (in addition to increasing CNS stimulation, concurrent use with pseudoephedrine may increase the cardiovascular effects of either or both medications and the risk of adverse effects
Digitalis glycosides (concurrent use with pseudoephedrine may increase the risk of cardiac arrhythmias; caution and electrocardiographic monitoring are very important if concurrent use is necessary)
Levodopa (concurrent use with pseudoephedrine may increase the possibility of cardiac arrhythmias; dosage reduction of the sympathomimetic is recommended)
Monoamine oxidase (MAO) inhibitors, including furazolidone, procarbazine, and selegiline (concurrent use may prolong and intensify the cardiac stimulant and vasopressor effects of pseudoephedrine because of release of catecholamines, which accumulate in intraneuronal storage sites during MAO inhibitor therapy, resulting in headache, cardiac arrhythmias, vomiting, or sudden and severe hypertensive and/or hyperpyretic crises; pseudoephedrine should not be administered during or within 14 days following administration of MAO inhibitors.
Nitrates (concurrent use with pseudoephedrine may reduce the antianginal effects of these medications.
Rauwolfia alkaloids (concurrent use may inhibit the action of pseudoephedrine by depleting catecholamine stores.
Sympathomimetics, other (in addition to possibly increasing CNS stimulation, concurrent use may increase the cardiovascular effects of either the other sympathomimetics or pseudoephedrine and the potential for side effects.
Thyroid hormones (concurrent use may increase the effects of either these medications or pseudoephedrine; thyroid hormones enhance risk of coronary insufficiency when sympathomimetic agents are administered to patients with coronary artery disease; dosage adjustment is recommended, although problem is reduced in euthyroid patients)
Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).
Presentation
Benacold-DX Syrup 100 ml Bottle
Dextromethorphan (DXM or DM) is an antitussive drug. It is one of the active ingredients used to prevent coughs in many over-the-counter cold and cough medicines. Dextromethorphan has also found other uses in medicine, ranging from pain relief to psychological applications. It is sold in syrup, tablet, and lozenge forms manufactured under several different brand names and generic labels. In its pure form, dextromethorphan occurs as a white powder.
Dextromethorphan is the dextrorotatory enantiomer of the methyl ether of levorphanol, an opioid analgesic. It is also a stereoisomer of levomethorphan, an opioid analgesic. It is named according to IUPAC rules as (+)-3-methoxy-17-methyl-9α,13α,14α-morphinan. As the pure free base, dextromethorphan occurs as an odorless, white to slightly yellow crystalline powder. It is freely soluble in chloroform and essentially insoluble in water. Dextromethorphan is commonly available as the monohydrated hydrobromide salt, however some newer extended-release formulations contain dextromethorphan bound to an ion exchange resin based on polystyrene sulfonic acid.
Dosage and Administration
Gelcaps
Adults and Children (12 yr of age and older)
PO 30 mg every 6 to 8 h (max, 120 mg/day).
Lozenges
Adults and children (12 yr of age and older)
PO 5 to 15 mg every 1 to 4 h (max, 120 mg/day).
Children (6 to younger than 12 yr of age)
PO 5 to 10 mg every 1 to 4 h (max, 60 mg/day).
Liquid and syrup
Adults and Children (12 yr of age and older)
PO 10 to 20 mg every 4 h or 30 mg every 6 to 8 h (max, 120 mg/day).
Children (6 to younger than 12 yr of age)
PO 15 mg every 6 to 8 h (max, 60 mg/day).
Children (2 to younger than 6 yr of age)
PO 7.5 mg every 6 to 8 h (max, 30 mg/day).
Extended-release suspension
Adults and Children (12 yr of age and older)
PO 60 mg every 12 h (max, 120 mg/day).
Children (6 to younger than 12 yr of age)
PO 30 mg every 12 h (max, 60 mg/day).
Children (2 to younger than 6 yr of age)
PO 15 mg every 12 h (max, 30 mg/day).
Dexromethorphan Hydrobromide (DM) is the the cough suppressant ingredient in most over the counter ( OTC ) cough medicines. It was introduced back in the late '60s as a substitute for codiene, which was the the usual, frequently abused cough suppressant ingredient at the time (such as in Robitussin AC, which was a combination of alcohol and codiene). DM is actually an analog of an opiate ( Meaning that it was engineered from opiates), but does not register as an opiate, nor does it have any of the usual opiate characterictics, such as anesthesia, sedation or physical withdrawl. So, if you're looking for an opiate high, you are looking in the wrong place. Technically, it's molecular structure has been changed so much that its closest chemical cousin is actually Phenylcyclidine (PCP), but is little closer to Ketamine in it's effects. In the recreational sense, its an extremely powerful disassociative hallucinogen of such potency that I would easily put it in the same catagory of strength with LSD and mushrooms ( In fact , in some cases, and doses, I would consider it to be more powerful, but thats just me. Also, I had the privilege of getting most of the LSD in my life shipped from Haite Street in San Francisco, so I know good LSD...), but with noticably different effects.
Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.
This drug should not be used with the following medications because very serious interactions may occur: MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, selegiline, tranylcypromine), epinephrine for low blood pressure, metrizamide, sibutramine, cabergoline, pergolide, halofantrine, pimozide.
If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this medication.
Tell your doctor or pharmacist if you have stopped taking MAO inhibitors within the last 2 weeks.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: narcotic pain medications (e.g., codeine), tramadol, memantine, muscle relaxants, medicine for sleep/anxiety (e.g., alprazolam, diazepam, zolpidem), bupropion, tricyclic antidepressants (e.g., amitriptyline), psychiatric medicines (e.g., chlorpromazine, risperidone, trazodone), drugs for Parkinson's disease (e.g., anticholinergics such as benztropine, trihexyphenidyl), anti-seizure drugs (e.g., carbamazepine), scopolamine, antispasmodics (e.g., atropine, belladonna alkaloids), other antihistamines (e.g., diphenhydramine, dimenhydrinate), cough-and-cold products, diphenhydramine or other antihistamines applied to the skin (e.g., anti-itch cream, ointment, spray).
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
Action
Depresses cough reflex through direct effect on cough center in medulla. Has no expectorant action and does not inhibit ciliary action. Although related to opioids structurally, lacks analgesic and addictive properties.
Availability
Gelcaps: 15 mg, 30 mg
Liquid: 3.5 mg/5 ml, 5 mg/5 ml, 7.5 mg/5 ml, 15 mg/5 ml
Lozenges: 5 mg, 7.5 mg
Oral suspension (extended-release): 30 mg/5 ml
Syrup: 7.5 mg/5 ml, 10 mg/15 ml
Comparison with the patient's adverse outcomes:
Name Count (% of total reports)
Vomiting 33 (4.57%)
Top overall drug interactions, adverse side effects:
Name Count (% of total reports)
1 Pyrexia 62 (7.46%)
2 Nausea 56 (6.74%)
3 Sepsis 53 (6.38%)
4 Haemoglobin decreased 50 (6.02%)
5 Dehydration 43 (5.17%)
6 Diarrhoea 42 (5.05%)
7 Hypotension 41 (4.93%)
8 Abdominal pain 34 (4.09%)
9 Vomiting 33 (3.97%)
10 Alanine aminotransferase increased 29 (3.49%)
Top long term (1+ years on drugs) drug interactions, side effects:
Name Count (% of total reports)
1 Nervousness 2 (22.22%)
2 Diarrhoea 2 (22.22%)
3 Nausea 2 (22.22%)
4 General physical health deterioration 2 (22.22%)
5 Cough 2 (22.22%)
6 Small intestinal obstruction 1 (11.11%)
7 Proteinuria 1 (11.11%)
8 Coronary artery disease 1 (11.11%)
9 Weakness 1 (11.11%)
10 Dizziness (excl vertigo) 1 (11.11%)
Mode of Action
• It inhibits phosphodiesterase, which degrades cyclic nucleotides, hence increased amount of intra cellular CAMP molecules causing smooth muscle relaxation.
• Blockade of adenosine receptors (which enhance release of histamine and other inflammatory mediator and bronchospasm).
• Overall effect of the drug is to produce.
- Bronchodilation by bronichial muscle relaxation.
- Suppression of response of airways to stimuli.
- Cardiac stimulation (increases heart rate and cardiac output).
- Respiratory stimulation it also induces diuresis.
Pharmacokinetics
It is well absorbed orally, distributed in all tissuses, crosses the placentas and is secreted in milk. It is 60% plasma protein bound. It is extensively metabolized in the liver by demethylation and oxidation. Only 10 % is excreted as unchanged drug, rest are excreted as changed metabolites in the urine. Steady plasma levels are obtained 1 –3 days after initiation of therapy after which half-life is 6 –8 hours. In neonates most of drug is excreted unchanged in urine and clearance is very slow.
ANTICOLD/ANTIALLERGICS
AMBROXOL HCI 15MG + TERBUTALINE SULPHATE 1.5 MG + GUAHENESIN 50 MG + MENTHOL 1 MG
AMBROXOL HCI 30MG + TERBUTALINE SULPHATE 1.5MG + GUAHENESIN 50MG + MENTHOL 1MG
AMBROXOL HCL 15 MG + CHLORPHENIRAMINE MALEATE 2 MG + GUAHENESIN 50 MG + MENTHOL 1MG
AMBROXOL HYDROCHLORIDE 15 MG + SALBUTAMOL 1 MG
BROMHEXINE HYDROCHLORIDE 4 MG + TERBUTALINE SULPHATE 1.25 MG GUAHENSIN 50 MG + FLAVOURED MENTHOLATED SYRUPY BASE QS.
BROMHEXINE HYDROCHLORIDE 8MG + DEXTROMETHORPHAN HYDROBROMIDE 10MG + AMMONIUM CHLORIDE 100MG + MENTHOL 5MG
CETIRIZINE DI-HYDROCHLORIDE 5 MG
CETIRIZINE DIHYDROCHLORIDE 5MG + DEXTROMETHORPHAN HBr 10MG + AMBROXOL HCI 15MG +
CETIRIZINE HYDROCHLORIDE 2.5MG + PHENYLEPHRINE HYDROCHLORIDE 5MG + PARACETAMOL 125MG
CHLORPHENIRAMINE MALEATE 4MG + CODEINE PHOSPHATE 10MG
CHLORPHENIRAMINE MALEATE 2 MG + AMMONIUM CHLORIDE 100 MG + SODIUM CITRATE 50 MG + FLAVOURED MENTHOLATED SYRUPY BASE QS
CHLORPHENIRAMINE MELEATE 2MG + DEXTROMETHORPHAN HYDROBROMIDE 10MG + PHENYLEPHRINE HYDRCHLORIDE 5MG + FLAVOURED SYRUPY BASE Q.S.
CHLORPHENIRAMINE MELEATE 2MG + DEXTROMETHORPHAN HYDROBROMIDE 10MG + PHENYLEPHRINE HYDRCHLORIDE 5MG + FLAVOURED SYRUPY BASE Q.S.
CHLORPHENIRAMINE MELEATE 4 MG + AMMONIUM CHLORIDE 120 MG + SODIUM CITRATE 50 MG
CHLORPHENIRAMINE MELEATE 4MG +DEXTROMETHORPHAN HBr. 10MG + GUAHENESIN 100MG + PHENYLEPHRINE HCI 10MG
DEXTROMETHORPHAN HYDROBROMIDE 10 MG + CHLORPHENIRAMINE MALEATE 4 MG
DEXTROMETHORPHEN HBr 5 MG + PHENYLEPHRINE HCI 5 MG + AMBROXOL HCI 15 MG + MENTHOL 2.5 MG
DHENHYDRAMINE HCI 14.08 MG + AMMONIUM CHLORIDE 138 MG + SODIUM CITRATE57.03MG + MENTHOL 1.14MG
Ambroxol Hydrochloride 15mg Terbutaline Sulphate 1.25mg Guahenesin 50mg Flavored base
Dextromethorphan HBr. 15mg Cetirizine HCl 5mg Pseudoephedrine HCl 60mg Ambroxol HCl
Dextromethorphan Hydrobromide 10mg Pseudoephedrine HCl 10mg Chlorpheniramine Maleate 2mg Menthol
PARACETAMOL 125MG + CETIRIZINE HYDROCHLORIDE 5MG + PHENYLEPHRINE HYDROCHLORIDE 2.5MG
PARACETAMOL 125MG + PHENYLPROPANOLAMINE HCI 10MG + CHLORPHENIRAMINE MALEATE 2MG
PHENYLEPHRINE HYDROCHLORIDE 5MG + CHLORPHENIRAMINE MALEATE 2MG
PSEUDOEPHEDRINE HCI 15MG + CETIRIZINE DIHYDROCHLORIDE 2.5MG + PARACETAMOL 12G MG +
TERBUTALINE SULPHATE 1.25MG + BROMHEXINE Hcl 4 MG + GUAHENESIN 50 MG + MENTHOL 2.5 MG
TERBUTALINE SULPHATE 2.5 MG + BROMHEXINE HcI 8 MG + GUAHENESIN 100 MG + MENTHOL 5 MG
Decoff Syrup
Each 5ml contains:
Codeine Phosphate I.P. 10 mg
Chlorpheniramine Maleate I.P. 4 mg
Mucovent Pd Syrup
Each 5ml contains:
Choline Theophyllinate B.P. 50 mg
Equivalent to Salbutamol 1.0 mg
Bromhexine Hydrochloride 8.0 mg
Mucovent Expectorant Syrup
Each 5ml contains:
Terbutaline Sulphate I.P. 1.25 mg
Ambroxol Hydrochloride B.P. 30 mg
Menthol 1 mg
Mucovent Tablet
Each uncoated tablet contains:
Terbutaline Sulphate I.P. 2 mg
Etofylline B.P. 100 mg
Bromhexine Hydrochloride I.P. 8 mg
Mocovent Forte Tablet
Each uncoated tablet contains:
Terbutaline Sulphate I.P. 2.5 mg
Etofylline B.P. 200 mg
Bromhexine Hydrochloride I.P. 8 mg
Codmaleate C. Syrup
Each 5ml contains:
Codeine Phosphate I.P. 10 mg
Chlorpheniramine Maleate I.P. 4 mg
Drykof
Each 5ml contains:
Dextromethorphan Hydrobromide I.P. 5 mg
Pseudoephedrine Hydrochloride I.P 15 mg
Cetrizine Hydrochloride B.P 2.5 mg
Menthol I.P. 1.25 mg
Cozin Forte Tab
Each film coated tablet:
Promethazine Hydrochloride I.P. 25 mg
Codeine Phosphate I.P. 30 mg
Cozin Linctus
Each 5ml contains:
Codeine Phosphate I.P. 10 mg
Chlorpheniramine Maleate I.P. 4 mg
Soma Linctus Codin
Each 5ml contains:
Codeine Phosphate I.P. 10 mg
Chlorpheniramine Maleate I.P. 4 mg
Zycof Syrup
Each 5ml contains:
Codeine Phosphate I.P. 10 mg
Chlorpheniramine Maleate I.P. 4 mg
Somavent -X Syrup
Each 5ml contains:
Salbutamol Sulphate I.P.
Equivalent to salbutamol 1 mg
Bromhexine Hydrochloride B.P. 4 mg
Guaiphenesin U.S.P. 50 mg
Menthol B.P. 1 mg
Angekof Syrup
Each 5ml (teaspoonful) contains:
Chlorpheniramine Maleate I.P. 4 mg
Codeine Phosphate I.P 10 mg
Cough Expectorant
Each 5ml (teaspoonful) contains:
Chlorpheniramine Maleate I.P. 2 mg
Ammonium Chloride I.P. 104 mg
Menthol I.P. 0.87 mg
Sodium Citrate I.P. 50 mg
Woktil Tablet
Each uncoated tablet contains:
Diphenoxylate Hydrochloride I.P. 2.5 mg
Atropine Sulphate I.P. 0.025 mg
Zencodex Cough Syrup
Each 5ml contains:
Codeine Phosphate I.P. 10 mg
Chlorpheniramine Maleate I.P. 4 mg
Enzol Suspension
Each 10ml contains:
Albendazole U.S.P. 400 mg
Chlorpheniramine Maleate I.P. 4 mg
Celkof Cough Syrup
Each 5ml contains:
Dextromethorphan Hydrobromide I.P. 10 mg
Chlorpheniramine Maleate I.P. 4 mg
Ankorex Syrup
Each 5ml contains:
Guaiphenesin I.P. 100 mg
Phenylpropanolamine Hydrochloride B.P. 25 mg
Chlorpheniramine Maleate I.P. 4 mg
Dextromethorphan Hydrobromide I.P. 10 mg
Cynorin Cold Releif Tabs
Each 5ml contains:
Paracetamol I.P. 500 mg
Caffeine I.P. 15 mg
Chlorpheniramine Maleate I.P. 2 mg
Phenylephrine HCL I.P. 5.0 mg
Celtine Cough Syrup
Each 5ml contains:
Paracetamol I.P. 170 mg
Phenylpropanolamine Hydrochloride B.P. 8.0 mg
Chlorpheniramine Maleate I.P. 1.5 mg
Dextromethorphan Hydrobromide I.P. 5.0 mg
Cophold Cough Syrup
Each 5ml contains:
Dextromethorphan Hydrobromide I.P. 10 mg
Chlorpheniramine Maleate I.P. 4 mg
In - Vent Syrup
Each 5ml contains:
Salbutamol Sulphate I.P.
Equivalent to salbutamol 1 mg
Etofylline I.P. 85 50 mg
Banacof C. Syrup
Each 5ml contains:
Diphenhydramine Hydrochloride I.P. 14.08 mg
Ammonium Chloride I.P. 0.138 mg
Sodium Citrate I.P. 57.03 mg
Menthol I.P. 1.14 mg
Brosal- G Syrup
Each 10ml contains:
Salbutamol Sulphate B.P.
Equivalent to salbutamol 2 mg
Bromhexine Hydrochloride B.P. 4 mg
Guaiphenesin U.S.P. 100 mg
Menthol B.P. 1 mg
Nucodin Cough Syrup
Each 5ml contains:
Codeine Phosphate I.P. 10 mg
Chlorpheniramine Maleate I.P. 4 mg
Zycodeen Syrup
Each 5ml contains:
Codeine Phosphate I.P. 10 mg
Chlorpheniramine Maleate I.P. 4 mg
Phenylpropanolamine (PPA; Accutrim, Dexatrim), also known as norephedrine and oxyamphetamine, is a psychoactive drug of the phenethylamine and amphetamine chemical classes which is used as a stimulant, decongestant, and anorectic agent.[1][2] It is commonly used in prescription and over-the-counter cough and cold preparations. In veterinary medicine, it is used to control urinary incontinence in dogs under trade names Propalin and Proin.
The FDA is taking steps to remove phenylpropanolamine hydrochloride from all drug products due to the risk of hemorrhagic stroke. FDA has significant concerns because of the seriousness of stroke and the inability to predict who is at risk.
Ingredients / Trade names:
1.
2. Phenylpropanolamine
* Amfed TD (Legere Pharmaceuticals)
* Ami-Tex
* Codimal
* Conex
* Contuss
* Despec
* Dexatrim Phenylpropanolamine
* Dura-Vent
* Entex
* Gentab
* Guaipax
* Myminic
* Naldecon
* Nolex
* Partuss
* Phenoxine
* Phenyldrine
* Phenylfenesin
* Propagest
* Rhindecon
* Rhymed
* Snaplets
* ULR
* Vanex
Drug Interactions
Patients receiving other narcotic analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with hydrocodone may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced. The use of phenylpropanolamine with other sympathomimetic amines and MAO inhibitors may produce an additive elevation of blood pressure (see [#section-6 WARNINGS]).
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity, mutagenicity and reproduction studies have not been conducted with HYCOMINE.
Pregnancy
Teratogenic Effects: Pregnancy Category C
Animal reproduction studies have not been conducted with HYCOMINE. It is also not known whether HYCOMINE can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. HYCOMINE should be given to a pregnant woman only if clearly needed.
Nonteratogenic Effects
Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose.
Labor and Delivery
As with all narcotics, administration of HYCOMINE to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used.
