Alkem COLD

Perennial Allergic Rhinitis: Cetirizine (Alkem COLD) hydrochloride syrup is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing.

Chronic Urticaria: Cetirizine (Alkem COLD) hydrochloride syrup is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.

For systemic use of Paracetamol (Alkem COLD) Sante Naturelle: 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.

Phenylephrine (Alkem COLD) is used for the temporary relief of stuffy nose, sinus, and ear symptoms caused by the common cold, flu, allergies, or other breathing illnesses (e.g., sinusitis, bronchitis). This medication works by decreasing swelling in the nose and ears, thereby lessening discomfort and making it easier to breathe.

Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.

Cetirizine (Alkem COLD) is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Cetirizine (Alkem COLD) is used to treat cold or allergy symptoms such as sneezing, itching, watery eyes, or runny nose.

Cetirizine (Alkem COLD) is also used to treat itching and swelling caused by chronic urticaria (hives).

Cetirizine (Alkem COLD) may also be used for purposes not listed in this medication guide.

Paracetamol (Alkem COLD) (acetaminophen) is a pain reliever and a fever reducer. The exact mechanism of Paracetamol (Alkem COLD) of is not known.

Paracetamol (Alkem COLD) is used to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers. It relieves pain in mild arthritis but has no effect on the underlying inflammation and swelling of the joint.

Paracetamol (Alkem COLD) may also be used for other purposes not listed in this medication guide.

Phenylephrine (Alkem COLD) ophthalmic causes constriction of blood vessels in the eyes. It also enlarges the pupils, reduces the production of fluid in the eyes, and increases the amount of fluid that drains from the eyes.

Phenylephrine (Alkem COLD) ophthalmic available over-the-counter is used to relieve redness, burning, irritation, and dryness of the eye caused by wind, sun, and other minor irritants. Prescription-strength Phenylephrine (Alkem COLD) ophthalmic is used to constrict blood vessels in the eye and to dilate (make bigger) the pupil for conditions such as glaucoma, before surgery, and before eye examinations.

Phenylephrine (Alkem COLD) ophthalmic may also be used for purposes other than those listed in this medication guide.

Usual Adult Dose for Allergic Rhinitis

5 to 10 mg orally or chewed once a day

Usual Adult Dose for Urticaria

5 to 10 mg orally or chewed once a day

Usual Pediatric Dose for Allergic Rhinitis

6 months to 2 years: 2.5 mg orally once a day, 12 months and older may be increased to 2.5 mg orally twice a day.

2 to 5 years: 2.5 mg orally once a day, may be increased to 5 mg/day in 1 to 2 divided doses.

6 years or older: 5 to 10 mg orally or chewed once a day.

Usual Pediatric Dose for Urticaria

6 months to 2 years: 2.5 mg orally once a day, 12 months and older may be increased to 2.5 mg orally twice a day.

2 to 5 years: 2.5 mg orally once a day, may be increased to 5 mg/day in 1 to 2 divided doses.

6 years or older: 5 to 10 mg orally or chewed once a day.

Renal Dose Adjustments

CrCl less than 30 mL/min: 5 mg orally or chewed once a day.

Use of Cetirizine (Alkem COLD) is not recommended in children under 6 years of age with renal impairment due to the difficulty in reliably administering doses less than 2.5 mg (1/2 teaspoonful) and the lack of pharmacokinetic and safety information of Cetirizine (Alkem COLD) in such patients.

Liver Dose Adjustments

5 mg orally or chewed once a day

Use of Cetirizine (Alkem COLD) is not recommended in children under 6 years of age with hepatic impairment due to the difficulty in reliably administering doses less than 2.5 mg (1/2 teaspoonful) and the lack of pharmacokinetic and safety information of Cetirizine (Alkem COLD) in such patients.

Precautions

In clinical trials, the occurrence of somnolence has been reported. Due caution should therefore be exercised when driving a car or operating potential dangerous machinery. Concurrent use of alcohol or other CNS depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur.

Dialysis

Cetirizine (Alkem COLD) is not significantly removed by hemodialysis, thus supplementary dosing is not required following hemodialysis. The recommended dosage for patients on hemodialysis is 5 mg orally or chewed once a day.

Usual Adult Paracetamol (Alkem COLD) Dose for Fever:

General Dosing Guidelines: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours orally or rectally.

Paracetamol (Alkem COLD) 500mg tablets: Two 500 mg tablets orally every 4 to 6 hours

Usual Adult Paracetamol (Alkem COLD) Dose for Pain:

General Dosing Guidelines: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours orally or rectally.

Paracetamol (Alkem COLD) 500mg tablets: Two 500 mg tablets orally every 4 to 6 hours

Usual Pediatric Dose for Fever:

Oral or Rectal:

<=1 month: 10 to 15 mg/kg/dose every 6 to 8 hours as needed.

>1 month to 12 years: 10 to 15 mg/kg/dose every 4 to 6 hours as needed (Maximum: 5 doses in 24 hours)

Fever: 4 months to 9 years: Initial Dose: 30 mg/kg (Reported by one study (n=121) to be more effective in reducing fever than a 15 mg/kg maintenance dose with no difference regarding clinical tolerance.)

>=12 years: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours.

Usual Pediatric Dose for Pain:

Oral or Rectal:

<=1 month: 10 to 15 mg/kg/dose every 6 to 8 hours as needed.

>1 month to 12 years: 10 to 15 mg/kg/dose every 4 to 6 hours as needed (Maximum: 5 doses in 24 hours)

Fever: 4 months to 9 years: Initial Dose: 30 mg/kg (Reported by one study (n=121) to be more effective in reducing fever than a 15 mg/kg maintenance dose with no difference regarding clinical tolerance.)

>=12 years: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours.

Prolonged exposure to air or strong light may cause oxidation and discoloration. Do not use if solution is brown or contains a precipitate.

Vasoconstriction and Pupil Dilatation

Phenylephrine (Alkem COLD) (Phenylephrine (Alkem COLD) hydrochloride ophthalmic solution) hydrochloride 10 percent ophthalmic solutions are especially useful when rapid and powerful dilatation of the pupil and reduction of congestion in the capillary bed are desired. A drop of a suitable topical anesthetic may be applied, followed in a few minutes by 1 drop of the Phenylephrine (Alkem COLD) (Phenylephrine (Alkem COLD) hydrochloride ophthalmic solution) hydrochloride 10 percent ophthalmic solutions on the upper limbus. The anesthetic prevents stinging and consequent dilution of the solution by lacrimation. It may occasionally be necessary to repeat the instillation after one hour, again preceded by the use of the topical anesthetic.

Uveitis: Posterior Synechiae

Phenylephrine (Alkem COLD) (Phenylephrine (Alkem COLD) hydrochloride ophthalmic solution) hydrochloride 10 percent ophthalmic solutions may be used in patients with uveitis when synechiae are present or may develop. The formation of synechiae may be prevented by the use of the 10 percent ophthalmic solutions and atropine to produce wide dilatation of the pupil. It should be emphasized, however, that the vasoconstrictor effect of Phenylephrine (Alkem COLD) (Phenylephrine (Alkem COLD) hydrochloride ophthalmic solution) hydrochloride may be antagonistic to the increase of local blood flow in uveal infection.

To free recently formed posterior synechiae, 1 drop of the 10 percent ophthalmic solutions may be applied to the upper surface of the cornea. On the following day, treatment may be continued if necessary. In the interim, hot compresses should be applied for five or ten minutes three times a day, with 1 drop of a 1 or 2 percent solution of atropine sulfate before and after each series of compresses.

Glaucoma

In certain patients with glaucoma, temporary reduction of intraocular tension may be attained by producing vasoconstriction of the intraocular vessels; this may be accomplished by placing 1 drop of the 10 percent ophthalmic solutions on the upper surface of the cornea. This treatment may be repeated as often as necessary.

Phenylephrine (Alkem COLD) (Phenylephrine (Alkem COLD) hydrochloride ophthalmic solution) hydrochloride may be used with miotics in patients with wide angle glaucoma. It reduces the difficulties experienced by the patient because of the small field produced by miosis, and still it permits and often supports the effect of the miotic in lowering the intraocular pressure. Hence, there may be marked improvement in visual acuity after using Phenylephrine (Alkem COLD) (Phenylephrine (Alkem COLD) hydrochloride ophthalmic solution) hydrochloride in conjunction with miotic drugs.

Surgery

When a short-acting mydriatic is needed for wide dilatation of the pupil before intraocular surgery, the 10 percent ophthalmic solutions or 2.5 percent ophthalmic solution may be applied topically from 30 to 60 minutes before the operation.

Refraction

Prior to determination of refractive errors, Phenylephrine (Alkem COLD) (Phenylephrine (Alkem COLD) hydrochloride ophthalmic solution) hydrochloride 2.5 percent ophthalmic solution may be used effectively with homatropine hydrobromide, atropine sulfate, or a combination of homatropine and cocaine hydrochloride.

For adults, a drop of the preferred cycloplegic is placed in each eye, followed in five minutes by 1 drop of Phenylephrine (Alkem COLD) (Phenylephrine (Alkem COLD) hydrochloride ophthalmic solution) hydrochloride 2.5 percent ophthalmic solution and in ten minutes by another drop of the cycloplegic. In 50 to 60 minutes, the eyes are ready for refraction.

For children, a drop of atropine sulfate 1 percent is placed in each eye, followed in 10 to 15 minutes by 1 drop of Phenylephrine (Alkem COLD) (Phenylephrine (Alkem COLD) hydrochloride ophthalmic solution) hydrochloride 2.5 percent ophthalmic solution and in five to ten minutes by a second drop of atropine sulfate 1 percent. In one to two hours, the eyes are ready for refraction.

For a “one application method,” Phenylephrine (Alkem COLD) (Phenylephrine (Alkem COLD) hydrochloride ophthalmic solution) hydrochloride 2.5 percent ophthalmic solution may be combined with a cycloplegic to elicit synergistic Phenylephrine (Alkem COLD). The additive effect varies depending on the patient. Therefore, when using a “one application method,” it may be desirable to increase the concentration of the cycloplegic.

Ophthalmoscopic Examination

One drop of Phenylephrine (Alkem COLD) (Phenylephrine (Alkem COLD) hydrochloride ophthalmic solution) hydrochloride 2.5 percent ophthalmic solution is placed in each eye. Sufficient mydriasis to permit examination is produced in 15 to 30 minutes. Dilatation lasts from one to three hours.

Diagnostic Procedures

Provocative Test for Angle Block in Patients with Glaucoma: The 2.5 percent ophthalmic solution may be used as a provocative test when latent increased intraocular pressure is suspected. Tension is measured before application of Phenylephrine (Alkem COLD) (Phenylephrine (Alkem COLD) hydrochloride ophthalmic solution) hydrochloride and again after dilatation. A 3 to 5 mm of mercury rise in pressure suggests the presence of angle block in patients with glaucoma; however, failure to obtain such a rise does not preclude the presence of glaucoma from other causes.

Shadow Test (Retinoscopy): When dilatation of the pupil without cycloplegic Phenylephrine (Alkem COLD) is desired for the shadow test, the 2.5 percent ophthalmic solution may be used alone.

Blanching Test: One or 2 drops of the 2.5 percent ophthalmic solution should be applied to the injected eye. After five minutes, examine for perilimbal blanching. If blanching occurs, the congestion is superficial and probably does not indicate iritis.

How supplied

In Mono-Drop ® plastic dropper bottle: Low surface tension solutions

2.5 percent ophthalmic solution - Phenylephrine (Alkem COLD) (Phenylephrine (Alkem COLD) hydrochloride ophthalmic solution) hydrochloride 2.5 percent in a sterile, isotonic, buffered, low surface tension vehicle with sodium phosphate, sodium biphosphate, boric acid, and, as antiseptic preservative, benzalkonium chloride, NF, 1:7500. The pH is adjusted with phosphoric acid or sodium hydroxide. Bottles of 15 mL (NDC 0024-1358-01).

10 percent ophthalmic solution- Phenylephrine (Alkem COLD) (Phenylephrine (Alkem COLD) hydrochloride ophthalmic solution) hydrochloride 10 percent in a sterile, buffered, low surface tension vehicle with sodium phosphate, sodium biphosphate, and, as antiseptic preservative, benzalkonium chloride 1:10,000. The pH is adjusted with phosphoric acid or sodium hydroxide. Bottles of 5 mL (NDC 0024-1359-01).

Viscous solution

10 percent ophthalmic solution- Phenylephrine (Alkem COLD) (Phenylephrine (Alkem COLD) hydrochloride ophthalmic solution) hydrochloride 10 percent in a sterile, buffered, viscous vehicle with sodium phosphate, sodium biphosphate, methylcellulose, and, as antiseptic preservative, benzalkonium chloride 1:10,000. The pH is adjusted with phosphoric acid or sodium hydroxide. Bottles of 5 mL (NDC 0024-1362-01).

Store at 25° C (77° F); excursions permitted to 15° - 30° C (59° - 86° F)

Manufactured for Sanofi-Synthelabo Inc. New York, NY 10016 by Abbott Laboratories North Chicago, IL 60064. Revised September 1999. FDA revision date: n/a

See also:
What is the most important information I should know about Cetirizine (Alkem COLD)?

Tablet: Cetirizine (Alkem COLD) should not be used except under special circumstances for patients with hepatic and renal function impairment.

The risk-benefit should be considered when medical problems eg, bladder neck obstruction, prostatic hypertrophy, urinary retention and glaucoma exists.

Syrup: Hypersensitivity to Cetirizine (Alkem COLD) dihydrochloride, hydroxyzine, any piperazine derivatives or to any of the excipients of Cetirizine (Alkem COLD). Patients with severe renal impairment CrCl <10 mL/min. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Cetirizine (Alkem COLD).

See also:
What is the most important information I should know about Paracetamol (Alkem COLD)?

Paracetamol (Alkem COLD) should not be used in patients who have previously exhibited hypersensitivity to aspirin and/or nonsteroidal antiinflammatory agents. Paracetamol (Alkem COLD) should not be given to patients with a recent history of gastrointestinal bleeding or in patients with bleeding disorders (e.g., hemophilia).

See also:
What is the most important information I should know about Phenylephrine (Alkem COLD)?

Do not touch the dropper to any surface, including the eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in the eye.

If you wear contact lenses, remove them before applying Phenylephrine (Alkem COLD) ophthalmic. Ask your doctor if contact lenses can be reinserted after application of the medication. Phenylephrine (Alkem COLD) ophthalmic may contains preservative (benzalkonium chloride), which may cause discoloration of contact lenses.

Do not use Phenylephrine (Alkem COLD) ophthalmic more often or continuously for longer than 48 to 72 hours without consulting a doctor. Chronic use of this medication may damage the blood vessels (veins and arteries) in the eyes. Consult a doctor if your symptoms do not improve or appear to worsen.

Use caution when driving, operating machinery, or performing other hazardous activities. Phenylephrine (Alkem COLD) ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

Use Cetirizine (Alkem COLD) orally disintegrating tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Do not remove the blister unit from the carton until you are ready to take Cetirizine (Alkem COLD) orally disintegrating tablets. Make sure that your hands are dry when you open the blister unit. Do not push the tablet through the foil. Peel back the foil on the blister unit and place the tablet on your tongue. The tablet dissolves quickly and can be swallowed with saliva. Cetirizine (Alkem COLD) orally disintegrating tablets may be taken with or without water. Take the tablet immediately after opening the blister unit. Do not store the removed tablet for future use.
• If you miss a dose of Cetirizine (Alkem COLD) orally disintegrating tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Cetirizine (Alkem COLD) orally disintegrating tablets.

Use Paracetamol (Alkem COLD) exactly as directed on the label, or as prescribed by your doctor.

Do not use more of this medication than is recommended. An overdose of Paracetamol (Alkem COLD) can cause serious harm. The maximum amount for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Using more Paracetamol (Alkem COLD) could cause damage to your liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking Paracetamol (Alkem COLD) and never use more than 2 grams (2000 mg) per day. If you are treating a child, use a pediatric form of Paracetamol (Alkem COLD). Carefully follow the dosing directions on the medicine label. Do not give the medication to a child younger than 2 years old without the advice of a doctor.

Measure the liquid form of Paracetamol (Alkem COLD) with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. You may need to shake the liquid before each use. Follow the directions on the medicine label.

The Paracetamol (Alkem COLD) chewable tablet must be chewed thoroughly before you swallow it.

Make sure your hands are dry when handling the Paracetamol (Alkem COLD) disintegrating tablet. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

To use the Paracetamol (Alkem COLD) effervescent granules, dissolve one packet of the granules in at least 4 ounces of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Do not take a Paracetamol (Alkem COLD) rectal suppository by mouth. It is for use only in your rectum. Wash your hands before and after inserting the suppository.

Try to empty your bowel and bladder just before using the Paracetamol (Alkem COLD) suppository. Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

For best results from the suppository, lie down and insert the suppository pointed tip first into the rectum. Hold in the suppository for a few minutes. It will melt quickly once inserted and you should feel little or no discomfort while holding it in. Avoid using the bathroom just after inserting the suppository.

Stop using Paracetamol (Alkem COLD) and call your doctor if:

• you still have a fever after 3 days of use;

• you still have pain after 7 days of use (or 5 days if treating a child);

• you have a skin rash, ongoing headache, or any redness or swelling; or

• if your symptoms get worse, or if you have any new symptoms.

Urine glucose tests may produce false results while you are taking Paracetamol (Alkem COLD). Talk to your doctor if you are diabetic and you notice changes in your glucose levels during treatment.

Store Paracetamol (Alkem COLD) at room temperature away from heat and moisture. The rectal suppositories can be stored at room temperature or in the refrigerator.

Use Phenylephrine (Alkem COLD) drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Phenylephrine (Alkem COLD) drops is for use in the eye only. Avoid contact with the nose or mouth.
• To use Phenylephrine (Alkem COLD) drops, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including your eye. Keep the container tightly closed.
• Do not wear contact lenses while you are using Phenylephrine (Alkem COLD) drops. Sterilize contact lenses according to the manufacturer's directions and check with your doctor before using them.
• Do not use Phenylephrine (Alkem COLD) drops if it is brown or contains particles.
• If you miss a dose of Phenylephrine (Alkem COLD) drops, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Phenylephrine (Alkem COLD) drops.

This combination medication is used to treat tension headaches. Acetaminophen helps to decrease the pain from the headache. Caffeine helps increase the effects of acetaminophen. Butalbital is a sedative that helps to decrease anxiety and cause sleepiness and relaxation.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to treat migraine headaches.

How to use Cetirizine (Alkem COLD)

Take this medication by mouth with or without food as directed by your doctor, usually every 4 hours as needed.

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

The dosage is based on your medical condition, age, and response to treatment. This medication works best if it is used as the first signs of a headache occur. If you wait until the headache has worsened, the medication may not work as well.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as nausea/vomiting, mental/mood changes, seizures) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Report any withdrawal reactions right away.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

Tell your doctor if you notice increased use of this medication, a worsening of headaches, an increase in the number of headaches, the medication not working as well, or use of this medication for more than 2 headache episodes a week. Do not take more than recommended. Your doctor may need to change your medication and/or add a separate medication to prevent the headaches.

This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

How to use Paracetamol (Alkem COLD)

Take this product by mouth as directed. Follow all directions on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist.

There are many brands and forms of acetaminophen available. Read the dosing instructions carefully for each product because the amount of acetaminophen may be different between products. Do not take more acetaminophen than recommended.

If you are giving acetaminophen to a child, be sure you use a product that is meant for children. Use your child's weight to find the right dose on the product package. If you don't know your child's weight, you can use their age.

For suspensions, shake the medication well before each dose. Some liquids do not need to be shaken before use. Follow all directions on the product package. Measure the liquid medication with the provided dose-measuring spoon/dropper/syringe to make sure you have the correct dose. Do not use a household spoon.

For rapidly-dissolving tablets, chew or allow to dissolve on the tongue, then swallow with or without water. For chewable tablets, chew thoroughly before swallowing.

Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

For effervescent tablets, dissolve the dose in the recommended amount of water, then drink.

Pain medications work best if they are used as the first signs of pain occur. If you wait until the symptoms have worsened, the medication may not work as well.

Do not take this medication for fever for more than 3 days unless directed by your doctor. For adults, do not take this product for pain for more than 10 days (5 days in children) unless directed by your doctor. If the child has a sore throat (especially with high fever, headache, or nausea/vomiting), consult the doctor promptly.

Tell your doctor if your condition persists or worsens or if you develop new symptoms. If you think you may have a serious medical problem, get medical help right away.

Use: Labeled Indications

Hypotension/shock: Treatment of hypotension, vascular failure in shock. Note: Not recommended for routine use in the treatment of septic shock; use should be limited until more evidence demonstrating positive clinical outcomes becomes available (Rhodes 2017).

Guideline recommendations:

Cardiogenic shock: The 2017 American Heart Association (AHA) scientific statement for the Contemporary Management of Cardiogenic Shock recommends Phenylephrine (Alkem COLD), if needed, be considered for initial vasoactive management of cardiogenic shock due to aortic stenosis, mitral stenosis, or dynamic left ventricular outflow tract (LVOT) obstruction (AHA [van Diepen 2017]).

Hypotension during anesthesia: As a vasoconstrictor in regional analgesia

Nasal congestion: As a decongestant [OTC]

Off Label Uses

Hypotension in patients with obstructive hypertrophic cardiomyopathy

Phenylephrine (Alkem COLD) is a pure alpha1 agonist that will increase systemic vascular resistance without increasing heart rate or contractility. This is advantageous in patients with obstructive hypertrophic cardiomyopathy and hypotension since increases in both heart rate and contractility may cause the obstruction to worsen, leading to a decrease in cardiac output. Other vasopressors like dopamine, epinephrine, and norepinephrine may increase contractility and/or heart rate. Additional trials may be necessary to further define the role of Phenylephrine (Alkem COLD) in this condition.

Based on the American Urological Association guidelines for the management of priapism, due to the low risk of cardiovascular side effects intracavernous injection of Phenylephrine (Alkem COLD) is recommended for ischemic priapism that persists following aspiration/irrigation.

See also:
What other drugs will affect Cetirizine (Alkem COLD)?

Tablet: Concurrent use with alcohol may potentiate the CNS depressant effects of Cetirizine (Alkem COLD); maprotiline or tricyclic antidepressants may potentiate the anticholinergic effects of either these medications or Cetirizine (Alkem COLD).

Monoamine oxidase (MAO) inhibitors are not recommended because the use may prolong and intensify the anticholinergic and CNS depressant effects of Cetirizine (Alkem COLD).

Concurrent use with ototoxic medications may mask the symptoms of ototoxicity eg, tinnitus, dizziness or vertigo; photosensitizing medications may cause additive photosensitizing effects.

Syrup: No interaction is observed for Cetirizine (Alkem COLD) with pseudoephedrine, cimetidine, ketoconazole, erythromycin and azithromycin. Small decrease in Cetirizine (Alkem COLD) clearance is observed when theophylline (400 mg once daily) is taken with Cetirizine (Alkem COLD). However, disposition of theophylline was not altered by concomitant Cetirizine (Alkem COLD) administration. Concomitant administration of Cetirizine (Alkem COLD) and macrolides or ketoconazole has never resulted clinically relevant EGG changes. Extent of exposure to Cetirizine (Alkem COLD) was increased by 40% when ritonavir is taken with Cetirizine (Alkem COLD). Disposition of ritonavir was slightly altered further to concomitant Cetirizine (Alkem COLD) administration.

See also:
What other drugs will affect Paracetamol (Alkem COLD)?

With the simultaneous use with inducers of microsomal liver enzymes, means having hepatotoxic effect, increasing the risk of hepatotoxic Paracetamol (Alkem COLD) of Paracetamol (Alkem COLD).

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 Paracetamol (Alkem COLD).

With the simultaneous use of oral contraceptives accelerated excretion of Paracetamol (Alkem COLD) from the body and may reduce its analgesic Paracetamol (Alkem COLD).

With the simultaneous use with urological means reduced their effectiveness.

With the simultaneous use of activated charcoal reduced bioavailability of Paracetamol (Alkem COLD).

When Paracetamol (Alkem COLD) Guardian 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 Paracetamol (Alkem COLD). A case of severe toxic liver injury.

Described cases of toxic effects of Paracetamol (Alkem COLD), while the use of isoniazid.

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

In applying cholestyramine a period of less than 1 h after administration of Paracetamol (Alkem COLD) 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 Paracetamol (Alkem COLD) and its increased concentration in blood plasma.

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

At simultaneous application of Paracetamol (Alkem COLD) Guardian with ethinylestradiol increases absorption of Paracetamol (Alkem COLD) 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).

See also:
What other drugs will affect Phenylephrine (Alkem COLD)?

Acetaminophen: May increase the serum concentration of Phenylephrine (Alkem COLD) (Systemic). Monitor therapy

Alpha1-Blockers: May diminish the vasoconstricting effect of Alpha1-Agonists. Similarly, Alpha1-Agonists may antagonize Alpha1-Blocker vasodilation. Monitor therapy

AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Benzylpenicilloyl Polylysine: Alpha1-Agonists may diminish the diagnostic effect of Benzylpenicilloyl Polylysine. Management: Consider use of a histamine skin test as a positive control to assess a patient's ability to mount a wheal and flare response. Consider therapy modification

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Monitor therapy

Chloroprocaine: May enhance the hypertensive effect of Phenylephrine (Alkem COLD) (Systemic). Monitor therapy

CloZAPine: May diminish the therapeutic effect of Phenylephrine (Alkem COLD) (Systemic). Monitor therapy

Cocaine (Topical): May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Consider therapy modification

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Monitor therapy

Ergot Derivatives: May enhance the hypertensive effect of Alpha1-Agonists. Ergot Derivatives may enhance the vasoconstricting effect of Alpha1-Agonists. Exceptions: Ergoloid Mesylates; Nicergoline. Avoid combination

FentaNYL: Alpha1-Agonists may decrease the serum concentration of FentaNYL. Specifically, fentanyl nasal spray serum concentrations may decrease and onset of effect may be delayed. Monitor therapy

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Monitor therapy

Hyaluronidase: May enhance the vasoconstricting effect of Phenylephrine (Alkem COLD) (Systemic). Management: Avoid the use of hyaluronidase to enhance dispersion or absorption of Phenylephrine (Alkem COLD). Use of hyaluronidase for other purposes in patients receiving Phenylephrine (Alkem COLD) may be considered as clinically indicated. Avoid combination

Iobenguane Radiopharmaceutical Products: Alpha1-Agonists may diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Avoid combination

Ioflupane I 123: Phenylephrine (Alkem COLD) (Systemic) may diminish the diagnostic effect of Ioflupane I 123. Monitor therapy

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Consider therapy modification

Monoamine Oxidase Inhibitors: May enhance the hypertensive effect of Alpha1-Agonists. While linezolid is expected to interact via this mechanism, management recommendations differ from other monoamine oxidase inhibitors. Refer to linezolid specific monographs for details. Exceptions: Linezolid. Avoid combination

Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Management: Concomitant use of ozanimod with sympathomimetic agents is not recommended. If combined, monitor patients closely for the development of hypertension, including hypertensive crises. Consider therapy modification

Propacetamol: May increase the serum concentration of Phenylephrine (Alkem COLD) (Systemic). Management: Monitor patients closely for increased side effects of Phenylephrine (Alkem COLD) if propacetamol is used concomitantly. Patients with underlying blood pressure issues or arrhythmias may need closer monitoring and may warrant consideration of alternative therapies. Monitor therapy

Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Monitor therapy

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Tricyclic Antidepressants: May enhance the therapeutic effect of Alpha1-Agonists. Tricyclic Antidepressants may diminish the therapeutic effect of Alpha1-Agonists. Monitor therapy

See also:
What are the possible side effects of Cetirizine (Alkem COLD)?

Pediatric studies were conducted with Cetirizine (Alkem COLD) hydrochloride. More than 1300 pediatric patients aged 6 to 11 years with more than 900 treated with Cetirizine (Alkem COLD) hydrochloride at doses of 1.25 to 10 mg per day were included in controlled and uncontrolled clinical trials conducted in the United States. The duration of treatment ranged from 2 to 12 weeks. Placebo-controlled trials up to 4 weeks duration included 168 pediatric patients aged 2 to 5 years who received Cetirizine (Alkem COLD), the majority of whom received single daily doses of 5 mg. A placebo-controlled trial 18 months in duration included 399 patients aged 12 to 24 months treated with Cetirizine (Alkem COLD) (0.25 mg/kg bid), and another placebo-controlled trial of 7 days duration included 42 patients aged 6 to 11 months who were treated with Cetirizine (Alkem COLD) (0.25 mg/kg bid).

The majority of adverse reactions reported in pediatric patients aged 2 to 11 years with Cetirizine (Alkem COLD) hydrochloride were mild or moderate. In placebo-controlled trials, the incidence of discontinuations due to adverse reactions in pediatric patients receiving up to 10 mg of Cetirizine (Alkem COLD) hydrochloride was uncommon (0.4% on Cetirizine (Alkem COLD) hydrochloride vs. 1.0% on placebo).

Table 1 lists adverse experiences which were reported for Cetirizine (Alkem COLD) hydrochloride 5 and 10 mg in pediatric patients aged 6 to 11 years in placebo-controlled clinical trials in the United States and were more common with Cetirizine (Alkem COLD) hydrochloride than placebo. Of these, abdominal pain was considered treatment-related and somnolence appeared to be dose-related, 1.3% in placebo, 1.9% at 5 mg and 4.2% at 10 mg. The adverse experiences reported in pediatric patients aged 2 to 5 years in placebo-controlled trials were qualitatively similar in nature and generally similar in frequency to those reported in trials with children aged 6 to 11 years.

In the placebo-controlled trials of pediatric patients 6 to 24 months of age, the incidences of adverse experiences, were similar in the Cetirizine (Alkem COLD) and placebo treatment groups in each study. Somnolence occurred with essentially the same frequency in patients who received Cetirizine (Alkem COLD) hydrochloride and patients who received placebo. In a study of 1 week duration in children 6 to 11 months of age, patients who received Cetirizine (Alkem COLD) exhibited greater irritability/fussiness than patients on placebo. In a study of 18 months duration in patients 12 months and older, insomnia occurred more frequently in patients who received Cetirizine (Alkem COLD) compared to patients who received placebo (9.0% v. 5.3%). In those patients who received 5 mg or more per day of Cetirizine (Alkem COLD) as compared to patients who received placebo, fatigue (3.6% v. 1.3%) and malaise (3.6% v. 1.8%) occurred more frequently.

Table 1.

Adverse Experiences Reported in Pediatric Patients Aged 6 to 11 Years in Placebo-Controlled United States Cetirizine (Alkem COLD) Hydrochloride Trials (5 or 10 mg Dose) Which Occurred at a Frequency of ≥2% in Either the 5-mg or the 10-mg Cetirizine (Alkem COLD) Hydrochloride Group, and More Frequently Than in the Placebo Group

The following events were observed infrequently (less than 2%), in either 3982 adults and children 12 years and older or in 659 pediatric patients aged 6 to 11 years who received Cetirizine (Alkem COLD) hydrochloride in U.S. trials, including an open adult study of six months duration. A causal relationship of these infrequent events with Cetirizine (Alkem COLD) hydrochloride administration has not been established.

Autonomic Nervous System: anorexia, flushing, increased salivation, urinary retention.

Cardiovascular: cardiac failure, hypertension, palpitation, tachycardia.

Central and Peripheral Nervous Systems: abnormal coordination, ataxia, confusion, dysphonia, hyperesthesia, hyperkinesia, hypertonia, hypoesthesia, leg cramps, migraine,

myelitis, paralysis, paresthesia, ptosis, syncope, tremor, twitching, vertigo, visual field defect.

Gastrointestinal: abnormal hepatic function, aggravated tooth caries, constipation, dyspepsia, eructation, flatulence, gastritis, hemorrhoids, increased appetite, melena, rectal hemorrhage, stomatitis including ulcerative stomatitis, tongue discoloration, tongue edema.

Genitourinary: cystitis, dysuria, hematuria, micturition frequency, polyuria, urinary incontinence, urinary tract infection.

Hearing and Vestibular: deafness, earache, ototoxicity, tinnitus.

Metabolic/Nutritional: dehydration, diabetes mellitus, thirst.

Musculoskeletal: arthralgia, arthritis, arthrosis, muscle weakness, myalgia.

Psychiatric: abnormal thinking, agitation, amnesia, anxiety, decreased libido, depersonalization, depression, emotional lability, euphoria, impaired concentration, insomnia, nervousness, paroniria, sleep disorder.

Respiratory System: bronchitis, dyspnea, hyperventilation, increased sputum, pneumonia, respiratory disorder, rhinitis, sinusitis, upper respiratory tract infection.

Reproductive: dysmenorrhea, female breast pain, intermenstrual bleeding, leukorrhea, menorrhagia, vaginitis.

Reticuloendothelial: lymphadenopathy.

Skin: acne, alopecia, angioedema, bullous eruption, dermatitis, dry skin, eczema, erythematous rash, furunculosis, hyperkeratosis, hypertrichosis, increased sweating, maculopapular rash, photosensitivity reaction, photosensitivity toxic reaction, pruritus, purpura, rash, seborrhea, skin disorder, skin nodule, urticaria.

Special Senses: parosmia, taste loss, taste perversion.

Vision: blindness, conjunctivitis, eye pain, glaucoma, loss of accommodation, ocular hemorrhage, xerophthalmia.

Body as a Whole: accidental injury, asthenia, back pain, chest pain, enlarged abdomen, face edema, fever, generalized edema, hot flashes, increased weight, leg edema, malaise, nasal polyp, pain, pallor, periorbital edema, peripheral edema, rigors.

Occasional instances of transient, reversible hepatic transaminase elevations have occurred during Cetirizine (Alkem COLD) therapy. Hepatitis with significant transaminase elevation and elevated bilirubin in association with the use of Cetirizine (Alkem COLD) hydrochloride has been reported.

Post-Marketing Experience

In the post-marketing experience period, the following additional rare, but potentially severe adverse events have been reported: aggressive reaction, anaphylaxis, cholestasis, convulsions, glomerulonephritis, hallucinations, hemolytic anemia, hepatitis, orofacial dyskinesia, severe hypotension, stillbirth, suicidal ideation, suicide and thrombocytopenia.

See also:
What are the possible side effects of Paracetamol (Alkem COLD)?

Effects due to the presence of acetylsalicylic acid.

Accidents awareness with respiratory or skin reactions (angioedema, urticaria, asthma, anaphylactic shock);

Cross hypersensitivity reactions with NSAIDs and with tartrazine;

At low doses recommended for the use of Paracetamol (Alkem COLD), side effects of aspirin are generally limited to some irritation of the gastro-intestinal tract.

At higher doses, side effects include gastrointestinal mucosal erosions, gastric ulcer or duodenal ulcer, occult blood loss, melena.

Acetylsalicylic acid may also increase the tendency to bleeding and bleeding time (the lengthening of bleeding continues 4-6 days after stopping the drug).

It may also worsen renal function including cases of pre-existing condition (the long-term use can cause chronic kidney disease).

The signs of salicylic overdose described under.

Effects due to the presence of Paracetamol (Alkem COLD).

At the doses and duration of recommended treatment, side effects are usually negligible, but the prolonged use of Paracetamol (Alkem COLD) in therapeutic doses large (2-4 g per day, or 10-20 tablets Paracetamol (Alkem COLD)) may cause the appearance chronic hepatitis. This justifies the recommendations of caution especially in patients with liver disease prior.

Very rarely, it can produce thrombocytopenia.

The acute liver toxicity in overdose massive (doses greater than 8 g of Paracetamol (Alkem COLD)) is described in paragraph overdose.

See also:
What are the possible side effects of Phenylephrine (Alkem COLD)?

Applies to Phenylephrine (Alkem COLD): intravenous solution

In addition to its needed effects, some unwanted effects may be caused by Phenylephrine (Alkem COLD) (the active ingredient contained in Phenylephrine (Alkem COLD)). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking Phenylephrine (Alkem COLD), check with your doctor or nurse immediately:

Incidence not known:

• Blurred vision
• chest pain or discomfort
• difficult or labored breathing
• dizziness
• fainting
• fast, slow, or irregular heartbeat
• headache
• nausea or vomiting
• nervousness
• pain in the shoulders, arms, jaw, or neck
• pounding in the ears
• sweating
• tightness in the chest
• unusual tiredness

If any of the following symptoms of overdose occur while taking Phenylephrine (Alkem COLD), get emergency help immediately:

Symptoms of overdose:

• Feeling of fullness in the head
• pounding or rapid pulse
• tingling in the arms or legs
• vomiting

Minor Side Effects

Some of the side effects that can occur with Phenylephrine (Alkem COLD) may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Incidence not known:

• Heartburn
• itching skin
• nausea
• pain in the neck
• pain or discomfort in chest, upper stomach, or throat

Cetirizine (Alkem COLD) HCl is a piperazine derivative and a metabolite of hydroxyzine. It competes reversibly with histamine to block the histamine (H₁) receptor sites. Cetirizine (Alkem COLD) HCl is considered a long-acting nonsedating antihistamine and has some mast-cell stabilizing activity.

Paracetamol (Alkem COLD) is an organic compound that consists of a six-membered ring containing two opposing nitrogen atoms. Paracetamol (Alkem COLD) exists as small alkaline deliquescent crystals with a saline tasteacinol was introduced to medicine as a solvent for uric acid. When taken into the body the drug is partly oxidized and partly eliminated unchanged. Outside the body, piperazine has a remarkable power to dissolve uric acid and producing a soluble urate, but in clinical experience it has not proved equally successfulacinol was first introduced as an anthelmintic in 1953. A large number of piperazine compounds have anthelmintic Paracetamol (Alkem COLD). Their mode of Paracetamol (Alkem COLD) is generally by paralysing parasites, which allows the host body to easily remove or expel the invading organism.

Phenylephrine (Alkem COLD) is a sympathomimetic amine that acts predominantly on α-adrenergic receptors. It is mainly used to treat nasal congestion, but may also be useful in treating hypotension and shock, hypotension during spinal anaesthesia, prolongation of spinal anaesthesia, paroxysmal supraventricular tachycardia, symptomatic relief of external or internal hemorrhoids, and to increase blood pressure as an aid in the diagnosis of heart murmurs.