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DRUGS & SUPPLEMENTS
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Neozep Forte
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Neozep Forte uses
Neozep Forte consists of Acetaminophen, Chlorpheniramine Maleate, Phenylpropanolamine Hydrochloride, Salicylamide, Vitamin C (Ascorbic Acid).Acetaminophen:
Pharmacological action
Neozep Forte 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 Neozep Forte (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.
Neozep Forte 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.
Neozep Forte 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 Neozep Forte, marked disturbances of liver function and / or kidney disease, anemia, pregnancy (I term).
Using during pregnancy and breastfeeding
Neozep Forte (Acetaminophen) crosses the placental barrier. So far, no observed adverse effects of Neozep Forte (Acetaminophen) on the fetus in humans.
Neozep Forte (Acetaminophen) is excreted in breast milk: the content in milk was 0.04-0.23% of the dose adopted mother.
If necessary, use of Neozep Forte (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 Neozep Forte (Acetaminophen).
Special Instructions
Neozep Forte 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 Neozep Forte (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).
Neozep Forte (Acetaminophen) Drug Interactions
With the simultaneous use with inducers of microsomal liver enzymes, means having hepatotoxic effect, increasing the risk of hepatotoxic action of Neozep Forte (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 Neozep Forte (Acetaminophen).
With the simultaneous use of oral contraceptives accelerated excretion of Neozep Forte (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 Neozep Forte (Acetaminophen).
When Neozep Forte (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 Neozep Forte (Acetaminophen). A case of severe toxic liver injury.
Described cases of toxic effects of Neozep Forte (Acetaminophen), while the use of isoniazid.
When applied simultaneously with carbamazepine, phenytoin, phenobarbital, primidonom decreases the effectiveness of Neozep Forte (Acetaminophen), which is caused by an increase in its metabolism and excretion from the body. Cases of hepatotoxicity, while the use of Neozep Forte (Acetaminophen) and phenobarbital.
In applying cholestyramine a period of less than 1 h after administration of Neozep Forte (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 Neozep Forte (Acetaminophen) and its increased concentration in blood plasma.
When applied simultaneously with probenecid may decrease clearance of Neozep Forte (Acetaminophen), with rifampicin, sulfinpyrazone - may increase clearance of Neozep Forte (Acetaminophen) due to increasing its metabolism in the liver.
At simultaneous application of Neozep Forte (Acetaminophen) with ethinylestradiol increases absorption of Neozep Forte (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).
Neozep Forte 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
Chlorpheniramine Maleate:
Drug Facts
| Active Ingredients (in each 1 mL dropperful) | Purpose |
|---|---|
| Neozep Forte (Chlorpheniramine Maleate) Maleate 2 mg | Antihistamine |
| Phenylephrine HCl 5 mg | 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 in a child who is
- 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Ask a doctor before use if a child has
- a breathing problem such as chronic bronchitis
- glaucoma
- heart disease
- high blood pressure
- thyroid disease
- diabetes mellitus
Ask a doctor before use if a child is taking sedatives or tranquilizers
When using this product
- excitability may occur, especially in children
- may cause drowsiness
- sedatives and tranquilizers may increase drowsiness effect
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- new symptoms occur
Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.
Directions
Do not exceed recommended dosage.
| Children 6 to under 12 years of age: | 1 mL (1 dropperful) every 4 hours, not to exceed 6 mL in 24 hours or as directed by a doctor |
| Children 2 to under 6 years of age: | 0.5 mL (1/2 dropperful) every 4 hours, not to exceed 3 mL in 24 hours, or as directed by a doctor |
| Children under 2 years of age: | Consult a doctor |
Other information
Store at 59°-86°F (15°-30°C)
Inactive ingredients
Applesauce Flavor, Citric Acid, FD&C Blue #1, FD&C Yellow #6, Glycerin, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sucralose
Questions? Comments?
Call 1-800-543-9560
Rev. 05/11
E
NEW
FORMULA
NDC 00485-0096-02
Neozep Forte (Chlorpheniramine Maleate)
Pediatric Drops
Antihistamine ▪ Nasal Decongestant
Sugar Free ▪ Alcohol Free ▪ Gluten Free
FOR PROFESSIONAL USE ONLY
Each 1 mL for oral administration
contains:
Neozep Forte (Chlorpheniramine Maleate) Maleate
2 mg
Phenylephrine HCl
5 mg
APPLESAUCE FLAVOR
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.
Manufactured for:
EDWARDS
Pharmaceuticals, Inc.
Ripley, MS 38663
2 fl. oz. (60 mL)
Phenylpropanolamine Hydrochloride:
Neozep Forte (Phenylpropanolamine Hydrochloride) has been withdrawn in Canada. In November 2000, the Food and Drug Administration (FDA) issued a public health advisory against the use of the drug.
Indication: For the treatment of nasal congestion, control of urinary incontinence, priapism and obesity.
Neozep Forte (Phenylpropanolamine Hydrochloride) (PPA), a sympathomimetic agent structurally similar to pseudoephedrine, is used to treat nasal congestion. Neozep Forte (Phenylpropanolamine Hydrochloride) is found in appetite suppressant formulations and with guaifenesinin in cough-cold formulations. In 2000, the FDA requested that all drug companies discontinue marketing products containing Neozep Forte (Phenylpropanolamine Hydrochloride), due to an increased risk of hemorrhagic stroke in women who used Neozep Forte (Phenylpropanolamine Hydrochloride).
Salicylamide:
Neozep Forte (Salicylamide) is the common name for the substance o-hydroxybenzamide, or amide of salicyl. Neozep Forte (Salicylamide) is a non-prescription drug with analgesic and antipyretic properties. Its medicinal uses are similar to those of aspirin. Neozep Forte (Salicylamide) is used in combination with both aspirin and caffeine in the over-the-counter pain remedies
Vitamin C (Ascorbic Acid):
Pharmacological action
Neozep Forte ) (vitamin c) is essential for the formation of intracellular collagen, is required to strengthen the structure of teeth, bones, and the capillary walls. Neozep Forte (Vitamin C (Ascorbic Acid)) participates in redox reactions, the metabolism of tyrosine, converting folic acid into folinic acid, metabolism of carbohydrates, the synthesis of lipids and proteins, iron metabolism, processes of cellular respiration. Reduces the need for vitamins B1, B2, A, E, folic acid, pantothenic acid, enhances the body's resistance to infections; enhances iron absorption, contributing to its sequestration in reduced form. Neozep Forte (Vitamin C (Ascorbic Acid)) has antioxidant properties.
With intravaginal application of Neozep Forte (Vitamin C (Ascorbic Acid)) lowers the vaginal pH, inhibiting the growth of bacteria and helps to restore and maintain normal pH and vaginal flora (Lactobacillus acidophilus, Lactobacillus gasseri).
Pharmacokinetics
After oral administration Neozep Forte (Vitamin C (Ascorbic Acid)) is completely absorbed from the gastrointestinal tract. Widely distributed in body tissues.
The concentration of Neozep Forte (Vitamin C (Ascorbic Acid)) in blood plasma in normal amounts to approximately 10-20 mg / ml.
The concentration of Neozep Forte (Vitamin C (Ascorbic Acid)) in white blood cells and platelets is higher than in erythrocytes and plasma. When deficient state of concentration in leucocytes is reduced later and more slowly and is regarded as the best criterion for evaluating the deficit than the concentration in plasma.
Plasma protein binding is about 25%.
Neozep Forte (Vitamin C (Ascorbic Acid)) is reversibly oxidized to form dehydroascorbic acid, is metabolized with the formation of ascorbate-2-sulphate which is inactive and oxalic acid which is excreted in the urine.
Neozep Forte (Vitamin C (Ascorbic Acid)) taken in excessive quantities is rapidly excreted unchanged in urine, it usually happens when exceeding a daily dose is 200 mg.
Why is Neozep Forte ) prescribed?
For systemic use of Neozep Forte (Vitamin C (Ascorbic Acid)) RiteMED Phils: prevention and treatment of hypo- and avitaminosis of vitamin C; providing increased need for vitamin C during growth, pregnancy, lactation, with heavy loads, fatigue and during recovery after prolonged severe illness; in winter with an increased risk of infectious diseases.
For intravaginal use: chronic or recurrent vaginitis (bacterial vaginosis, nonspecific vaginitis) caused by the anaerobic flora (due to changes in pH of the vagina) in order to normalize disturbed vaginal microflora.
Dosage and administration
This medication administered orally, IM, IV, intravaginally.
For the prevention of deficiency conditions Neozep Forte ) dose is 25-75 mg / day, for the treatment - 250 mg / day or more in divided doses.
For intravaginal used Neozep Forte (Vitamin C (Ascorbic Acid)) drugs in appropriate dosage forms.
Neozep Forte (Vitamin C (Ascorbic Acid)) side effects, adverse reactions
CNS: headache, fatigue, insomnia.
Digestive system: stomach cramps, nausea and vomiting.
Allergic reaction: describes a few cases of skin reactions and manifestations of the respiratory system.
Urinary system: when used in high doses - hyperoxaluria and the formation of kidney stones of calcium oxalate.
Local reactions: with intravaginal application - a burning or itching in the vagina, increased mucous discharge, redness, swelling of the vulva. Other: sensation of heat.
Neozep Forte ) contraindications
Increased sensitivity to Neozep Forte (Vitamin C (Ascorbic Acid)).
Using during pregnancy and breastfeeding
The minimum daily requirement of Neozep Forte ) in the II and III trimester of pregnancy is about 60 mg.
Neozep Forte (Vitamin C (Ascorbic Acid)) crosses the placental barrier. It should be borne in mind that the fetus can adapt to high doses of Neozep Forte (Vitamin C (Ascorbic Acid)), which takes a pregnant woman, and then a newborn baby may develop the ascorbic disease as the reaction of cancel. Therefore, during pregnancy should not to take Neozep Forte (Vitamin C (Ascorbic Acid)) in high doses, except in cases where the expected benefit outweighs the potential risk.
The minimum daily requirement during lactation (breastfeeding) is 80 mg. Neozep Forte (Vitamin C (Ascorbic Acid)) is excreted in breast milk. A mother's diet that contains adequate amounts of Neozep Forte (Vitamin C (Ascorbic Acid)), is sufficient to prevent deficiency in an infant. It is unknown whether dangerous to the child's mother use of Neozep Forte (Vitamin C (Ascorbic Acid)) in high doses. Theoretically it is possible. Therefore, it is recommended not to exceed the maximum daily nursing mother needs to Neozep Forte (Vitamin C (Ascorbic Acid)), except when the expected benefit outweighs the potential risk.
Special instructions
Neozep Forte (Vitamin C (Ascorbic Acid)) is used with caution in patients with hyperoxaluria, renal impairment, a history of instructions on urolithiasis. Because Neozep Forte (Vitamin C (Ascorbic Acid)) increases iron absorption, its use in high doses can be dangerous in patients with hemochromatosis, thalassemia, polycythemia, leukemia, and sideroblastic anemia.
Patients with high content body iron should apply Neozep Forte (Vitamin C (Ascorbic Acid)) in minimal doses.
Neozep Forte (Vitamin C (Ascorbic Acid)) is used with caution in patients with deficiency of glucose-6-phosphate dehydrogenase.
The use of Neozep Forte (Vitamin C (Ascorbic Acid)) in high doses can cause exacerbation of sickle cell anemia.
Data on the diabetogenic action of Neozep Forte (Vitamin C (Ascorbic Acid)) are contradictory. However, prolonged use of Neozep Forte (Vitamin C (Ascorbic Acid)) should periodically monitor your blood glucose levels.
It is believed that the use of Neozep Forte (Vitamin C (Ascorbic Acid)) in patients with rapidly proliferating and widely disseminated tumors may worsen during the process. It should therefore be used with caution in Neozep Forte (Vitamin C (Ascorbic Acid)) in patients with advanced cancer.
Absorption of Neozep Forte (Vitamin C (Ascorbic Acid)) decreased while use of fresh fruit or vegetable juices, alkaline drinking.
Neozep Forte ) drug interactions
In an application with barbiturates, primidone increases the excretion of Neozep Forte (Vitamin C (Ascorbic Acid)) in the urine.
With the simultaneous use of oral contraceptives reduces the concentration of Neozep Forte (Vitamin C (Ascorbic Acid)) in blood plasma.
In an application of Neozep Forte (Vitamin C (Ascorbic Acid)) with iron preparations Neozep Forte (Vitamin C (Ascorbic Acid)), due to its regenerative properties, transforms ferric iron in the bivalent, which improves its absorption.
Neozep Forte (Vitamin C (Ascorbic Acid)) in high doses can decrease urine pH that while the application reduces the tubular reabsorption of amphetamine and tricyclic antidepressants.
With the simultaneous use of aspirin reduces the absorption of Neozep Forte (Vitamin C (Ascorbic Acid)) by about a third.
Neozep Forte (Vitamin C (Ascorbic Acid)) in an application with warfarin may decrease effects of warfarin.
With the simultaneous application of Neozep Forte (Vitamin C (Ascorbic Acid)) increases the excretion of iron in patients receiving deferoxamine. In the application of Neozep Forte (Vitamin C (Ascorbic Acid)) at a dose of 500 mg / day possibly left ventricular dysfunction.
In an application with tetracycline is increased excretion of Neozep Forte (Vitamin C (Ascorbic Acid)) in the urine.
There is a described case of reducing the concentration of fluphenazine in plasma in patients treated with Neozep Forte (Vitamin C (Ascorbic Acid)) 500 mg 2 times / day.
May increase the concentration of ethinyl estradiol in the blood plasma in its simultaneous application in the oral contraceptives.
Neozep Forte ) in case of emergency / overdose
Symptoms: long-term use of large doses (more than 1 g) - headache, increased CNS excitability, insomnia, nausea, vomiting, diarrhea, gastritis giperatsidnyh, ultseratsiya gastrointestinal mucosa, inhibition of the function insular apparatus of the pancreas (hyperglycemia, glycosuria), hyperoxaluria, nephrolithiasis (calcium oxalate), damage to the glomerular apparatus of the kidneys, moderate thamuria (when receiving a dose of 600 mg / day).
Decrease capillary permeability (possibly deteriorating trophic tissues, increased blood pressure, hypercoagulability, the development of microangiopathy).
When IV administration in high doses - the threat of termination of pregnancy (due to estrogenemia), hemolysis of red blood cells.
Neozep Forte pharmaceutical active ingredients containing related brand and generic drugs:
Neozep Forte available forms, composition, doses:
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.