Cofdex CC

Acetaminophen:

• Pharmacological action
• Why is Cofdex CC (Acetaminophen) prescribed?
• Cofdex CC dosage and administration
• Cofdex CC side effects, adverse reactions
• Contraindications
• Using during pregnancy and breastfeeding
• Special Instructions
• Cofdex CC (Acetaminophen) Drug Interactions
• Cofdex CC in case of emergency / overdose
• Cofdex CC (Acetaminophen) reviews

Pharmacological action

Cofdex CC is an analgesic-antipyretic. It has analgesic, antipyretic and weak anti-inflammatory action. The mechanism of action is associated with inhibition of prostaglandin synthesis, the predominant influence on the thermoregulation center in the hypothalamus, enhances heat transfer.

Why is Cofdex CC (Acetaminophen) prescribed?

Pain weak and moderate intensity of different genesis (including headache, migraine, toothache, neuralgia, myalgia, algomenorrhea; pain in trauma, burns). Fever in infectious and inflammatory diseases.

Cofdex CC dosage and administration

Oral or rectally adults and adolescents with a body weight over 60 kg is used in a single dose of 500 mg, the multiplicity of admission - up to 4 times / Maximum duration of treatment - 5-7 days.

Maximum dose: single - 1 g, daily - 4 g.

Single dose for oral administration for children aged 6-12 years - 250-500 mg, 1-5 years - 120-250 mg, from 3 months to 1 year - 60-120 mg, up to 3 months - 10 mg / kg. Single dose rectal in children aged 6-12 years - 250-500 mg, 1-5 years - 125-250 mg.

Multiplicity - 4 at intervals of not less than 4 h. The maximum duration of treatment - 3 days.

Maximum dose: 4 single dose per day.

Cofdex CC side effects, adverse reactions

Digestive system: rarely - dyspepsia; long-term use at high doses - hepatotoxic effects, methemoglobinemia, renal dysfunction and liver, hypochromic anemia. Hemopoietic system: rarely - thrombocytopenia, leukopenia, pancytopenia, neutropenia, agranulocytosis. Allergic reactions: rarely - skin rash, itching, hives.

Contraindications

Chronic active alcoholism, increased sensitivity to Cofdex CC, marked disturbances of liver function and / or kidney disease, anemia, pregnancy (I term).

Using during pregnancy and breastfeeding

Cofdex CC (Acetaminophen) crosses the placental barrier. So far, no observed adverse effects of Cofdex CC (Acetaminophen) on the fetus in humans.

Cofdex CC (Acetaminophen) is excreted in breast milk: the content in milk was 0.04-0.23% of the dose adopted mother.

If necessary, use of Cofdex CC (Acetaminophen) during pregnancy and lactation (breastfeeding) should carefully weigh the potential benefits of therapy for the mother and the potential risk to the fetus or child.

In experimental studies found no embryotoxic, teratogenic and mutagenic action of Cofdex CC (Acetaminophen).

Special Instructions

Cofdex CC is used with caution in patients with disorders of the liver and kidneys, with benign hyperbilirubinemia, as well as in elderly patients.

With prolonged use of Cofdex CC (Acetaminophen) is necessary to monitor patterns of peripheral blood and functional state of the liver.

Used for treatment of premenstrual tension syndrome in combination with pamabrom (diuretic, a derivative of xanthine) and mepyramine (Histamine H1-receptors blocker).

Cofdex CC (Acetaminophen) Drug Interactions

With the simultaneous use with inducers of microsomal liver enzymes, means having hepatotoxic effect, increasing the risk of hepatotoxic action of Cofdex CC (Acetaminophen).

With the simultaneous use of anticoagulants may be slight to moderate increase in prothrombin time.

With the simultaneous use of anticholinergics may decrease absorption of Cofdex CC (Acetaminophen).

With the simultaneous use of oral contraceptives accelerated excretion of Cofdex CC (Acetaminophen) from the body and may reduce its analgesic action.

With the simultaneous use with urological means reduced their effectiveness.

With the simultaneous use of activated charcoal reduced bioavailability of Cofdex CC (Acetaminophen).

When Cofdex CC (Acetaminophen) applied simultaneously with diazepam may decrease excretion of diazepam.

There have been reports about the possibility of enhancing mielodepression effect of zidovudine while applying with Cofdex CC (Acetaminophen). A case of severe toxic liver injury.

Described cases of toxic effects of Cofdex CC (Acetaminophen), while the use of isoniazid.

When applied simultaneously with carbamazepine, phenytoin, phenobarbital, primidonom decreases the effectiveness of Cofdex CC (Acetaminophen), which is caused by an increase in its metabolism and excretion from the body. Cases of hepatotoxicity, while the use of Cofdex CC (Acetaminophen) and phenobarbital.

In applying cholestyramine a period of less than 1 h after administration of Cofdex CC (Acetaminophen) may decrease of its absorption.

At simultaneous application with lamotrigine moderately increased excretion of lamotrigine from the body.

With the simultaneous use of metoclopramide may increase absorption of Cofdex CC (Acetaminophen) and its increased concentration in blood plasma.

When applied simultaneously with probenecid may decrease clearance of Cofdex CC (Acetaminophen), with rifampicin, sulfinpyrazone - may increase clearance of Cofdex CC (Acetaminophen) due to increasing its metabolism in the liver.

At simultaneous application of Cofdex CC (Acetaminophen) with ethinylestradiol increases absorption of Cofdex CC (Acetaminophen) from the gut.

Enhances the effect of indirect anticoagulants (coumarin derivatives and indandione). Antipyretic and analgesic activity of caffeine increases, reduce - rifampicin, phenobarbital and alcohol (accelerated biotransformation, inducing microsomal liver enzymes).

Cofdex CC in case of emergency / overdose

At a reception in toxic doses (10-15 g in adults) may develop liver necrosis.

Symptoms of overdose may include: nausea, vomiting, loss of appetite, sweating, extreme tiredness, unusual bleeding or bruising, pain in the upper right part of the stomach, yellowing of the skin or eyes, flu-like symptoms

Dextromethorphan:

• Pharmacological action
• Pharmacokinetics
• Why is Cofdex CC prescribed?
• Dosage and administration
• Cofdex CC (Dextromethorphan) side effects, adverse reactions
• Cofdex CC contraindications
• Using during pregnancy and breastfeeding
• Special instructions
• Cofdex CC drug interactions
• Cofdex CC in case of emergency / overdose
• Cofdex CC (Dextromethorphan) reviews

Pharmacological action

Cofdex CC is an antitussive medication. Inhibiting the excitability of the cough center this medicine suppresses the cough of any origin. Cofdex CC (Dextromethorphan) has not addiction effects and it has no analgesic and hypnotic action. Cofdex CC (Dextromethorphan) starts to act after 10-30 minutes after oral administration, the duration of therapeutic action: 5-6 hours for adults and 6-9 hours for children. Cofdex CC (Dextromethorphan) is an optical isomer of levomethorphan which is similar to morphine. Due to optical isomerism this drug has no opioid effects. Cofdex CC (Dextromethorphan) used mainly for replacement of codeine as a cough suppressant. In addition to the cough suppressant this medication is used in medicine for diagnostic purposes and may be useful in various cases - from seizures to heroin addiction treatment, some chronic neurodegenerative diseases. These include amyotrophic lateral sclerosis (ALS) (Charcot's disease), disease of "mad cow and other prion diseases. Cofdex CC (Dextromethorphan) has also been used for the treatment of mental retardation, Parkinson's disease, in the treatment of lung and other cancers and to prevent tissue rejection in transplantation because of the (poorly known) effects of sigma ligands on tumor cells and immune system.

Pharmacokinetics

After oral administration Cofdex CC (Dextromethorphan) is completely absorbed from the gastrointestinal tract. C_max of Cofdex CC (Dextromethorphan) in plasma is reached after 2 h. This medication biotransformes in the liver. Up to 45% of this drug is excreted by kidneys and there was considerable individual variation in rates of excretion of individual metabolites.

Why is Cofdex CC prescribed?

Dry cough of different etiology.

Dosage and administration

For adults and children over 12 years Cofdex CC prescribed on 15 mg 4 times / day, children aged 6 years - 7.5 mg 4 times / day.

Cofdex CC (Dextromethorphan) side effects, adverse reactions

Drowsiness, nausea, dizziness.

Cofdex CC contraindications

Bronchial asthma, bronchitis, simultaneous reception of mucolytic.

Using during pregnancy and breastfeeding

During pregnancy and lactation (breastfeeding) Cofdex CC (Dextromethorphan) prescribed with caution, only in cases where the expected therapeutic effect for the mother outweighs the potential risk to the fetus or child.

Special instructions

With carefully administered Cofdex CC (Dextromethorphan) with impaired liver function.

Cofdex CC drug interactions

MAO inhibitors (including furazolidone, procarbazine, selegiline) when administered simultaneous with Cofdex CC (Dextromethorphan) may cause adrenergic crisis, collapse, coma, dizziness, agitation, increased blood pressure, hyperpyrexia, intracranial hemorrhage, lethargy, nausea, cramps, tremor. In combination with tricyclic antidepressants (amitriptyline, etc.) Cofdex CC (Dextromethorphan) may appeal serotonin syndrome and possible subsequent death. Amiodarone, fluoxetine, quinidine, inhibiting system cytochrome P450, may increase the drug concentration in the blood. Tobacco smoke can lead to increased secretion of glands in the background of inhibition of cough reflex. Some inhibitors of CYP450 (such as quinidine) increase and extended effects of this medicine.

Cofdex CC in case of emergency / overdose

Symptoms: excitement, dizziness, respiratory depression, impaired consciousness, decreased blood pressure, tachycardia, muscle hypertonicity, ataxia.

Treatment: mechanical ventilation, symptomatic agents.

Diphenhydramine:

• Pharmacological action
• Pharmacokinetics
• Why is Cofdex CC Xepa-Soul Pattinson prescribed?
• Dosage and administration
• Cofdex CC (Diphenhydramine) Xepa-Soul Pattinson side effects, adverse reactions
• Cofdex CC Xepa-Soul Pattinson contraindications
• Using during pregnancy and breastfeeding
• Special instructions
• Precautionary measures
• Cofdex CC (Diphenhydramine) Xepa-Soul Pattinson drug interactions
• Cofdex CC Xepa-Soul Pattinson in case of emergency / overdose
• Cofdex CC (Diphenhydramine) reviews

Pharmacological action

Cofdex CC Xepa-Soul Pattinson is a blocker of histamine H1-receptors. It has antiallergic activity, has a local anesthetic, antispasmodic and mild ganglion blocking action.

When Cofdex CC (Diphenhydramine) Xepa-Soul Pattinson administered orally Cofdex CC (Diphenhydramine) has a sedative and hypnotic effects, has a moderate antiemetic effect and has a central holinoliticheskoy activity.

When applied externally it has antiallergic effect.

Pharmacokinetics

Cofdex CC (Diphenhydramine) Xepa-Soul Pattinson is rapidly absorbed from the gastrointestinal tract. Bioavailability is 50%. C_max is achieved after 20-40 min (in the greatest concentration is determined in the lungs, spleen, kidneys, liver, brain and muscles). Binding to plasma proteins - 98-99%. Penetrates through the BBB. Metabolised mainly in the liver, partly - in the lungs and kidneys. T1/2 is 4-10 hours. Within one day completely removed kidneys as metabolites conjugated to glucuronic acid. Significant quantities are derived from milk and can cause sedation in infants (may be a paradoxical reaction characterized by hyperexcitability).

Why is Cofdex CC Xepa-Soul Pattinson prescribed?

Allergic reactions (urticaria, hay fever, angioedema), allergic conjunctivitis, vasomotor rhinitis, Henoch-Schonlein purpura, serum sickness, itchy dermatitis, sleep disorders (monotherapy or in combination with drugs), chorea, sea and air sickness, vomiting in pregnancy, Meniere's syndrome, premedication.

Dosage and administration

Oral, IV, IM, rectal, topical, intranasal, in the conjunctival sac. Oral dose of Cofdex CC Xepa-Soul Pattinson for adults is 30-50 mg 1-3 times / day. The treatment course is 10-15 days. As soporific - 50 mg at bedtime. IM in doses of 50-250 mg; IV in drip - 20-50 mg. When oral administered single dose for children under 1 year - 2-5 mg; from 2 to 5 years - 5-15 mg; of 6 to 12 years - 15-30 mg. Externally applied 1-2 times / day.

Cofdex CC (Diphenhydramine) Xepa-Soul Pattinson side effects, adverse reactions

Possible: a short-term numbness in the oral mucosa, drowsiness, weakness, decrease in psychomotor speed of reaction in children may be a paradoxical development of insomnia, irritability, and euphoria.

Rarely: dizziness, headache, dry mouth, nausea, photosensitivity, paresis of accommodation, poor coordination of movements, tremor.

Cofdex CC Xepa-Soul Pattinson contraindications

Closure glaucoma, prostatic hypertrophy, stenosing peptic ulcer, stenosis of the bladder neck, bronchial asthma, epilepsy, hypersensitivity to Cofdex CC (Diphenhydramine).

Using during pregnancy and breastfeeding

During pregnancy and lactation, Cofdex CC (Diphenhydramine) used with caution, according to strict indications, when the expected therapeutic effect for the mother outweighs the potential risk to the fetus or infant.

Special instructions

With careful use Cofdex CC (Diphenhydramine) during pregnancy and lactation.

During the period of treatment with Cofdex CC (Diphenhydramine) Xepa-Soul Pattinson should not be exposed to solar radiation should be avoided alcohol.

Used with caution in patients involved in potentially dangerous activities requiring attention and rapid psychomotor reactions.

Precautionary measures

Cofdex CC Xepa-Soul Pattinson is not recommended for SC injection. Since Cofdex CC (Diphenhydramine) has atropinopodobnym action should be cautious in its use: patients with recent respiratory infection in history (including asthma), increased intraocular pressure in hyperthyroidism, cardiovascular system, hypotension. Antihistamines drugs can reduce mental alertness as well as in adults and children and also cause agitation and hallucinations, convulsions and death in infants and children, especially in overdose. Precautions apply at age 60 and older because more likely to develop dizziness, sedation and hypotension. During treatment with Cofdex CC (Diphenhydramine) should avoid sun exposure. Should not be used during the drivers of vehicles and people, trade is connected with increased concentration. In the period of treatment should avoid drinking alcoholic beverages.

Cofdex CC (Diphenhydramine) Xepa-Soul Pattinson drug interactions

When Cofdex CC (Diphenhydramine) Xepa-Soul Pattinson applied simultaneously increases the effects of ethanol and drugs that depress the central nervous system.

With simultaneous use of Cofdex CC (Diphenhydramine) Xepa-Soul Pattinson and MAO inhibitors increase the anticholinergic activity of Cofdex CC (Diphenhydramine).

The antagonistic interaction observed with a joint appointment with psychostimulants.

Reduces the effectiveness of apomorphine as an emetic in the treatment of poisoning. Intensifies anticholinergic effects of drugs with anticholinergic activity.

Cofdex CC Xepa-Soul Pattinson in case of emergency / overdose

Symptoms: dry mouth, difficulty breathing, persistent mydriasis, flushing, depression or excitement (more common in children), CNS confusion; children - the development of convulsions and death.

Treatment: induction of vomiting, gastric lavage, the prescription of activated charcoal, symptomatic and supportive therapy on a background of careful monitoring of respiration and blood pressure levels.

Phenylephrine:

• Drug facts
• Purpose
• Uses
• Warnings
• Directions
• Other information
• Inactive ingredients
• Questions? comments?
• Product packaging
• Cofdex CC (Phenylephrine) reviews

Drug Facts

Active ingredients

(in each tablet)

Dexbrompheniramine Maleate 2 mg

Cofdex CC (Phenylephrine) Hydrochloride 10 mg

Purpose

Antihistamine

Nasal Decongestant

Uses

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes
• nasal congestion
• reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do not use this product

• if you are now taking a prescription monoamine oxidase inhibitor (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to enlargement of the prostate gland
• heart disease
• high blood pressure
• thyroid disease
• diabetes
  

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

• excitability may occur, especially in children
• may cause drowsiness
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase the drowsiness effect
• use caution when driving a motor vehicle or operating machinery
  

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• symptoms do not improve within 7 days or are accompanied by fever
  

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other information

Store at 15° - 30°C (59° - 86°F). Supplied in a tight, light-resistant container with a child-resistant cap. Cofdex CC (Phenylephrine) Tablets are dark purple, caplet-shaped, scored tablets, debossed "Poly" bisect "782" on one side and plain on the other.

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 aluminum lake, dibasic calcium phosphate dihydrate, FD &C Blue #1 aluminum lake, magnesium stearate, and silicified microcrystalline cellulose.

Questions? Comments?

Call1-800-882-1041

Manufactured for:

Poly Pharmaceuticals

Quitman, MS 39355 Rev. 02/12

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 60 tablets label:

NDC 50991-782-60

Cofdex CC (Phenylephrine)

Tablets

Antihistamine - Nasal Decongestant

Each tablet contains:

Dexbrompheniramine Maleate...2 mg

Cofdex CC (Phenylephrine) Hydrochloride...10 mg

60 Tablets

Usual

Dosage: See product foldout for full prescribing information.

Tamper evident by foil seal under cap. Do not use if foil seal is

broken or missing.

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

Store at controlled room temperature between 15°-30°C (59°-86°F).

Manufactured for:

Poly Pharmaceuticals

Quitman, MS 39355

Rev. 02/12

Cofdex CC (Phenylephrine) Tablets Packaging Cofdex CC (Phenylephrine) Tablets Packaging

Pseudoephedrine:

• Congestac
• Cofdex CC (Pseudoephedrine) reviews

Active ingredients (in each caplet)...Purpose

Guaifenesin 400 mg...Expectorant

Cofdex CC (Pseudoephedrine) hydrochloride 60 mg...Nasal decongestant

Uses

For temporarily relief of nasal congestion due to a cold, hay fever, or other upper respiratory allergies (allergic rhinitis), and to help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Uses

• temporarily relieves nasal congestion due to a cold, hay fever, or other upper respiratory allergies (allergic rhinitis).
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings

Do not exceed recommended dosage.

Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urinating due to an enlarged prostate gland

Stop use and ask a doctor if

• you get nervous, dizzy, or sleepless
• symptoms do not improve within 7 days or are accompanied by fever

If pregnant or breast-feeding, ask a health professional before use.

Keep this and all drugs out of reach of children. In case of overdose, get medical help or contact a poison control center immediately.

Directions

• adults and children 12 years and older, 1 caplet every 4 to 6 hours, not more than 4 caplets in 24 hours
• children 6 to under 12 years, ½ caplet every 4 to 6 hours, not more than 2 caplets in 24 hours
• children under 6 years, consult a physician

Inactive ingredients

croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and starch

Questions?

1-800-324-1880, 7:30am - 4:00pm Central, Mon.-Fri., or visit us at www.bfascher.com

Cofdex CC