Bula do remedy Fenergan

the package insert of the medicine Fenergan. Therapeutic class of antihistamines and Anti-emeticos. Active principles hydrochloride promethazine and Sulfoguaiacol.

what For?

Fenergan pills and Fenergan injectable is indicated for the treatment of allergic reactions and anaphylactic, in the prevention of vomiting after surgery and nausea of travel, among other indications.

Fenergan expectorant and Fernegan Expectorant Paediatric is indicated in coughs in general, especially the nature allergic, and bronchitis. It is also indicated in the obstructions in nasal (stuffy nose), sneezing, and runny eyes from inflammations of the respiratory tract.

Use adult and children above 2 years – Use of oral and injectable

Pharmacokinetics

How it works?

Fenergan Tablets and injectable solution is a medicine that has anti-allergic properties, sedative and antieméticas.

The clinical effects of Fenergan Pills are noticed within 20 minutes after administration and generally last 4 to 6 hours, although they may persist up to 12 hours.

Fenergan Expectorant and Fernegan Expectorant Paediatric has two substances with different properties: the promethazine, which decongests the respiratory tract, having a action non-allergenic; and the sulfoguaiacol, which works as an expectorant.

Dosage

How to use?

The choice of pharmaceutical form and dosage should be made in function of the disorder to be treated and exclusively under medical guidance.

Basically – and only for guidance – can be prescribed the following dosage:

Fenergan Pills

Adults: 2 to 6 tablets per day. These doses should be divided into two, three or four times, with the largest fraction for the night.

The injectable form should be reserved for cases of urgency, should the product be administered intramuscularly, in doses to be established by the doctor.

The administration of intravenous this product is well tolerated, but is not exempt from risk.

Administration of subcutaneous and/or intra-arterial should not be used.

Fernegan Expectorant

The recommended dose is 1 or 2 spoons of tea (5 mL) every 2 or 3 hours.

To soothe coughs predominantly nocturnal, it is sufficient, in general, a dose of 2 tablespoons of tea (5mL) at bedtime.

Fernegan Expectorant Paediatric

Children 2 to 6 years: 1 teaspoon of tea (5 mL), 3 to 5 times a day (every 8 hours to every 5 hours).

Above 6 years: 1 teaspoon of tea (5 mL) 4 to 6 times a day (every 6 hours to every 4 hours).

Side Effects

What are the evils that can cause me?

The side effects are originated from the pharmacological properties of the promethazine, and may, or may not, be related to the administered dose.

Some unwanted reactions were observed with the use of Fenergan, such as:

    the

  • Sedation, or drowsiness, more pronounced at the beginning of the treatment; dryness of the mouth and other mucous membranes, constipation, changes in accommodation, visual, mydriasis (pupil dilation), and palpitations, risk of urinary retention; decrease in the frequency of the heart or an increase in the frequency of heart); increase or decrease in blood pressure (more common with promethazine injectable), a sudden drop in blood pressure if you are standing; changes in balance, dizziness, decreased memory or concentration; lack of motor coordination, tremors (most often in the individual the elderly).
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  • Rarely: nausea and vomiting, were also described cases of tardive dyskinesia (repetitive movements, involuntary) after long-term management of certain antihistamines; dizziness. Mental confusion, and hallucinations.
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  • More rarely: agitation, nervousness, insomnia.
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  • can Also occur: erythema, eczema, purpura, edema, and more rarely, edema of Quincke; anaphylactic shock; photosensitization; have been reported very rare cases of allergic reactions, including rash, “rash”, and itching, and anaphylaxis; leukopenia, neutropenia, and exceptionally agranulocytosis; thrombocytopenia; hemolytic anemia.

Contraindications

When should I not use?

Fenergan should not be taken for:

    the

  • Patients with known hypersensitivity (intolerance, allergy to promethazine or other derivatives fenotiazínicos (a group of medicines promethazine), or to any component of the formula.
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  • Patients with blood clotting problems or a history of agranulocytosis (characterized by a large reduction in the number of blood cells called granulocytes) with other fenotiazínicos.
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  • Patients with risk of urinary retention linked to disorders uretroprostáticos (related to the urethra – the canal which leads the urine, and the prostate – the gland in the male reproductive system).
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  • Patients with angle-closure glaucoma (a disease which affects the cells of the retina – the eyes).
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  • In association to alcohol and sultoprida (See section Warning and Precautions – Drug Interactions).
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  • Women during breastfeeding (See section Warning and Precautions – Pregnancy and breastfeeding).

You must tell your doctor if you have problems of blood, urine, or glaucoma, or if you have knowledge of to have a sensitivity to promethazine or other derivatives fenotiazínicos.

This medicine is contraindicated for children under 2 years of age.

Warnings and Precautions

what should I know before using?

Considering the effects fotossensibilizantes phenothiazine (potential to cause sensitivity to light), exposure to sunlight or artificial light is not recommended during treatment with Fenergan.

In the case of persistence or worsening of allergic symptoms (shortness of breath, swelling, skin lesions, etc.) or signs associated with infection by a virus, you should re-evaluate the patient and conduct adopted.

you Must take into consideration the alcohol content in the formulation of Fenergan Expectorant.

Fenergan should be administered with caution in patients who are under treatment with tranquilizers in general, because there may be increased drowsiness. For the same reason, you should avoid alcoholic beverages during treatment.

You should take the Fernegan Expectorant, and Pills by mouth.

Fenergan should be used with caution in the following situations:

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  • Individuals (particularly older individuals) with increased sensitivity to sedation, to the fall of pressure when you’re on foot, and dizziness;
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  • In patients with constipation chronic because of the risk of ileus paralytic (obstruction of the intestine);
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  • In the event of prostatic hypertrophy (enlarged prostate).
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  • In individuals with certain disorders relating to the heart and circulatory system, because of the effects taquicardizantes (which increases the beats of the heart) and hipotensores (decreases the pressure) of the phenothiazines. In cases of insufficiency with severe liver and/or kidneys because of the risk of accumulation.
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  • As the other drugs, sedative or depressant of the CNS (Central Nervous System), Fenergan should be avoided in patients with a history of sleep apnea (pause in breathing during sleep).
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  • alcoholic beverages and drugs containing alcohol should be avoided during treatment with Fenergan
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  • In patients diabetics or diets hipoglicídicas, take into account the presence of sucrose in the formula of the product.

surveillance (clinical and, eventually, eletroencefalográfica), should be enhanced in epileptic patients due to the possibility of lowering the threshold epileptogênico of fenotiazínicos.

Fenergan in pregnancy and breast-feeding: tell your doctor the occurrence of pregnancy during treatment with Fenergan or after its termination. Inform the doctor if you are breast-feeding.

there is Not enough data about changes in the formation of the fetus due to the use of this medicine. Therefore, during pregnancy, Fenergan should be used only under medical guidance, evaluating always the risk benefit.

it is Not known whether promethazine is excreted in human milk. The use of this medicine is not recommended during breast-feeding.

This medicine should not be used by pregnant women without medical advice.

The intravenous injection should be applied with extreme caution to avoid extravasation or injection of intra-arterial inadvertent, that can cause necrosis and gangrene of the peripheral.

In the case of the patient complaining of pain during intravenous injection, stop the injection immediately, as this may be a sign of extravasation or injection of intra-arterial inadvertent. The intramuscular injection should also be applied with caution to avoid subcutaneous injection inadvertent, that can lead to necrosis local.

The elderly patients, due to the functions reduced in the liver and kidneys, that may be more likely to present adverse reactions, particularly symptoms of lack of motor coordination and tremors, and therefore, caution is advised in the administration of Fenergan in the elderly.

Not recommended for use in children below 12 years of age.

The use of promethazine should be avoided in children and adolescents with signs and symptoms suggestive of reye ‘ s Syndrome (a serious disease that affects the brain and liver and is reltriggered a viral infection and the use of drugs of the group of salicylates).

During treatment, the patient should not drive vehicles or operate machinery, as your skill and attention may be harmed.

Attention diabetics: Fenergan Tablet contains sugar (sugar powdered amiláceo 24 mg/tablet).

Attention diabetics: Fenergan Expectorant contains no sugar (975 mg/mL of the sugar liquid, and 1mg/mL of caramel).

Attention diabetics: Fenergan Expectorant Paediatric contains sugar (975mg/mL of the sugar liquid, and 2 mg/mL of caramel).

Drug Interactions

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  • Medicine-alcohol

Associations advised against: the association with alcohol increases the sedative effects of antihistamines H1. The alteration of vigilance can make dangerous driving of vehicles and operation of machinery. So it is recommended to avoid the intake of alcoholic beverages and drugs containing alcohol during the treatment.

    the

  • Medicine-medicine

Associations advised against: association with sultoprida presents a greater risk of changes to heart rhythm

Associations to be considered:

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  • action sedative the promethazine is additive to the effects of other CNS depressants (Central Nervous System), as derived morfínicos (narcotic analgesics and antitussígenos), barbiturates, methadone, clonidine, and similar compounds, sedatives, hypnotics, tricyclic antidepressants and anti-anxiety medications. Therefore, these agents should be avoided or administered in reduced doses to patients using promethazine.
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  • association with atropine and other substances atropínicas (antidepressants imipramínicos, antiparkinsonianos, anticholinergics, antispasmodics atropínicos, disopyramide, neuroleptics fenotiazínicos) may result in additive effects of the undesirable effects atropínicos such as urinary retention, constipation and dryness of the mouth.
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  • Avoid use with MAOIS, as they prolong and intensify the effects of the promethazine, such as dryness of the mouth, pupil dilation, increase in heart rate.

Overdose

what to do if someone use a larger amount than is recommended?

The treatment is essentially symptomatic and supportive.

gastric lavage should be done as soon as possible.

Only in extreme cases it becomes necessary to monitoring of the vital signs.

immediately Look for help doctor if you feel the following symptoms: from a mild Central Nervous System depression (drowsiness) and cardiovascular system (heart and blood vessels), a sudden pressure drop, decreased respiratory capacity, fainting, agitation (especially in children and the elderly), convulsion, dry mouth, dilated pupils and fixed, redness in the face and neck, gastrointestinal symptoms.

elderly Patients may present with agitation.

naloxone reverses some of the depressive effects, but not all. Hypotension severe, in general, responds to the administration of norepinephrine or phenylephrine.

Epinephrine should not be used, since its use in patients with blocking adrenergic partial can lower even more the blood pressure.

limited Experiences with dialysis indicates that it is not useful in these cases.

what should I do when I forget to use this medicine?

If you forget to administer a dose, administer it as soon as possible.

however, if it is almost time for your next dose, wait for this time, always in compliance with the range determined by the dosage.

Never should be administered two doses at the same time.