Consists of ascorbic acid, paracetamol, pheniramine maleate, Phenylephrine hydrochloride
What is Ascorbic acid?
ascorbic acid occurs naturally in foods such as citrus fruit, tomatoes, potatoes, and leafy vegetables. Ascorbic acid is important for bones and connective tissues, muscles, and blood vessels. Ascorbic acid also helps the body absorb iron, which is needed for red blood cell production.
Ascorbic acid is used to treat and prevent Ascorbic acid deficiency.
Ascorbic acid may also be used for purposes not listed in this medication guide.
Ascorbic acid indications
For systemic use of Ascorbic acid Atlantic Laboratories: prevention and treatment of hypo- and avitaminosis of Ascorbic acid; providing increased need for Ascorbic acid 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.
How should I use Ascorbic acid?
Use Ascorbic acid as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Ascorbic acid may be taken with or without food.
- You may drop the dose of Ascorbic acid directly into your mouth or mix it with cereal, milk, or water.
- Take Ascorbic acid with a full glass of water (8 oz/240 mL). Do not lie down for 30 minutes after taking Ascorbic acid.
- Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
- If you miss a dose of Ascorbic acid, 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 Ascorbic acid.
Uses of Ascorbic acid in details
ascorbic acid is used to prevent or treat low levels of Ascorbic acid in people who do not get enough of the vitamin from their diets. Most people who eat a normal diet do not need extra ascorbic acid. Low levels of Ascorbic acid can result in a condition called scurvy. Scurvy may cause symptoms such as rash, muscle weakness, joint pain, tiredness, or tooth loss.
Ascorbic acid plays an important role in the body. It is needed to maintain the health of skin, cartilage, teeth, bone, and blood vessels. It is also used to protect your body's cells from damage. It is known as an antioxidant.
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 vitamin may also be used with other vitamins for a certain eye condition (macular degeneration).
How to use Ascorbic acid
Take this vitamin by mouth with or without food, usually 1 to 2 times daily. Follow all directions on the product package, or take as directed by your doctor.
If you are taking the extended-release capsules, swallow them whole. Do not crush or chew extended-release capsules or tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split extended-release 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. Take this product with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise.
If you are taking the wafers or chewable tablets, chew them thoroughly and then swallow. If you are taking the lozenges, place the lozenge in your mouth and allow it to slowly dissolve.
If you are taking the powder, mix it thoroughly in the proper amount of liquid and stir well. Drink all of the liquid right away. Do not prepare a supply for future use. If you are using the liquid form of this vitamin, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.
Dosage is based on your medical condition and response to treatment.
Use this vitamin regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.
If you think you may have a serious medical problem, seek immediate medical attention.
Ascorbic acid description
Each tablet contains ascorbic acid 500 mg.
ascorbic acid is a vitamin that is freely soluble in water. The superior formulation of ascorbic acid assures substantial amounts per dose for prophylaxis and treatment of Ascorbic acid deficiencies. This preparation has a very delectable grape (Ascorbic acid Tablet) flavors.
Ascorbic acid dosage
Important Preparation and Administration Instructions
- Ascorbic acid vials contain 25, 000 mg of ascorbic acid and the largest recommended single dose is 200 mg. Do not give the entire contents of the vial to a single patient.
- Do not administer Ascorbic acid as an undiluted intravenous sensitive.
- Minimize exposure to light because Ascorbic acid is light sensitive.
- Ascorbic acid is supplied as a Pharmacy Bulk Package (PBP) which is intended for dispensing of single doses to multiple patients in a pharmacy admixture program and is restricted to the preparation of admixtures for infusion:
a. Use only in a suitable ISO Class 5 work area such as a laminar flow hood (or an equivalent clean air compounding area)
b. Penetrate each PBP vial closure only one time with a suitable sterile transfer device or dispensing set that allows measured dispensing of the contents. Given that pressure may develop within the vial during storage, excercise caution when withdrawing contents from the vial.
c. Once the closure system has been penetrated, complete all dispensing from the PBP vial within 4 hours. Each dose must be used immediately. Discard unused portion.
d. Prior to administration, Ascorbic acid must be diluted in a suitable infusion solution and the final solution for infusion must be isotonic (undiluted the osmolarity of Ascorbic acid is approximately 5,900 mOsmol/L). Prior to preparing the admixture for infusion, calculate the osmolarity of the intended admixture for infusion. Add one daily dose of Ascorbic acid directly to an appropriate volume of a suitable infusion solution (e.g., 5% Dextrose Injection, Sterile Water for Injection) and add appropriate solutes, as necessary, to make final solution isotonic. Sterile Water for Injection is highly hypotonic; adjust solute content, as necessary, to make thet final infusion solution isotonic prior to injection. Do not mix Ascorbic acid with solutions containing elemental compounds that can be reduced (e.g., copper). The concentration of ascorbic acid in the final, admixture solution for infusion is to be the range of 1 to 25 mg of ascorbic acid per mL. For example, for the largest recommended dose:
Add 200 mg of ascorbic acid (equivalent to 0.4 mL of Ascorbic acid) to 7.5 mL of Sterile Water for Injection to produce an infusion solution having an approximate osmolarity of 290 mOsmol/L. In this specific example, addition of solute is NOT necessary because the solution is isotonic.
e. Prepare the recommended dose based on the patient population [ see Dosage and Administration (2.2), (2.3)].
f. Visually inspect for particulate matter and discoloration prior to administration (the diluted Ascorbic acid solution should appear colorless to pale yellow).
g. Immediately administer the admixture for infusion as a slow intravenous infusion [ see Recommended Dosage, (2.2)]
Recommended Dosage
Table 1 provides recommended doses of Ascorbic acid based on patient population and infusion rates of diluted Ascorbic acid solution.
| Patient Population | Ascorbic acid Once Daily Dose (mg) | Infusion Rate of Diluted Ascorbic acid Solution (mg/minute) |
| Pediatric Patients age 5 months to less than 12 months | 50 | 1.3 |
| Pediatric Patients age 1 year to less than 11 years | 100 | 3.3 |
| Adults and Pediatric Patients 11 years and older | 200 | 33 |
The recommended maximum duration of daily treatment with Ascorbic acid is seven days. If no improvement in scorbutic symptoms is observed after one week of treatment, retreat until resolution of scorbutic symptoms is observed.
Repeat dosing is not recommended in pediatric patients less than 11 years of age.
Dosage Reductions in Specific Populations
Women who are pregnant or lactating and patients with glucose-6-dehydrogenase deficiency should not exceed the U.S. Recommended Dietary Allowance (RDA) or daily Adequate Intake (AI) level for ascorbic acid for their age group and condition [ see Warnings and Precautions (5.2) and Use in Specific Populations (8.1, 8.2)].
Ascorbic acid interactions
See also:
What other drugs will affect Ascorbic acid?
In an application with barbiturates, primidone increases the excretion of ascorbic acid in the urine.
With the simultaneous use of oral contraceptives reduces the concentration of ascorbic acid in blood plasma.
In an application of Ascorbic acid with iron preparations ascorbic acid, due to its regenerative properties, transforms ferric iron in the bivalent, which improves its absorption.
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 ascorbic acid by about a third.
Ascorbic acid in an application with warfarin may decrease effects of warfarin.
With the simultaneous application of ascorbic acid increases the excretion of iron in patients receiving deferoxamine. In the application of ascorbic acid at a dose of 500 mg / day possibly left ventricular dysfunction.
In an application with tetracycline is increased excretion of ascorbic acid in the urine.
There is a described case of reducing the concentration of fluphenazine in plasma in patients treated with 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.
Ascorbic acid side effects
See also:
What are the possible side effects of Ascorbic acid?
Applies to ascorbic acid: oral capsule, oral capsule extended release, oral capsule liquid filled, oral granule, oral liquid, oral lozenge/troche, oral powder, oral powder for solution, oral powder for suspension, oral solution, oral syrup, oral tablet, oral tablet chewable, oral tablet extended release, oral wafer
In addition to its needed effects, some unwanted effects may be caused by ascorbic acid (the active ingredient contained in Ascorbic acid). In the event that any of these side effects do occur, they may require medical attention.
Severity: Moderate
If any of the following side effects occur while taking ascorbic acid, check with your doctor or nurse as soon as possible:
Less common or rare: - with high doses
- Side or lower back pain
Minor Side Effects
Some of the side effects that can occur with ascorbic acid 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:
Less common or rare: - with high doses
- Diarrhea
- dizziness or faintness (with the injection only)
- flushing or redness of skin
- headache
- increase in urination (mild)
- nausea or vomiting
- stomach cramps
Ascorbic acid contraindications
See also:
What is the most important information I should know about Ascorbic acid?
There are no contraindications to the administration of ascorbic acid.
What is Paracetamol?
Paracetamol (acetaminophen) is a pain reliever and a fever reducer. The exact mechanism of Paracetamol of is not known.
Paracetamol 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 may also be used for other purposes not listed in this medication guide.
Paracetamol indications
For systemic use of Paracetamol Sante Naturelle: prevention and treatment of hypo- and avitaminosis of Paracetamol; providing increased need for Paracetamol 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.
How should I use Paracetamol?
Use paracetamol 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 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 could cause damage to your liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking paracetamol and never use more than 2 grams (2000 mg) per day. If you are treating a child, use a pediatric form of paracetamol. 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 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 chewable tablet must be chewed thoroughly before you swallow it.
Make sure your hands are dry when handling the paracetamol 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 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 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 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 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. Talk to your doctor if you are diabetic and you notice changes in your glucose levels during treatment.
Store paracetamol at room temperature away from heat and moisture. The rectal suppositories can be stored at room temperature or in the refrigerator.
Uses of Paracetamol in details
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
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.
Paracetamol description
Paracetamol is an organic compound that consists of a six-membered ring containing two opposing nitrogen atoms. Paracetamol 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. Their mode of Paracetamol is generally by paralysing parasites, which allows the host body to easily remove or expel the invading organism.
Paracetamol dosage
Usual Adult Paracetamol 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 500mg tablets: Two 500 mg tablets orally every 4 to 6 hours
Usual Adult Paracetamol 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 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.
Paracetamol interactions
See also:
What other drugs will affect Paracetamol?
With the simultaneous use with inducers of microsomal liver enzymes, means having hepatotoxic effect, increasing the risk of hepatotoxic Paracetamol of paracetamol.
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.
With the simultaneous use of oral contraceptives accelerated excretion of paracetamol from the body and may reduce its analgesic Paracetamol.
With the simultaneous use with urological means reduced their effectiveness.
With the simultaneous use of activated charcoal reduced bioavailability of paracetamol.
When Paracetamol 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. A case of severe toxic liver injury.
Described cases of toxic effects of paracetamol, while the use of isoniazid.
When applied simultaneously with carbamazepine, phenytoin, phenobarbital, primidonom decreases the effectiveness of paracetamol, which is caused by an increase in its metabolism and excretion from the body. Cases of hepatotoxicity, while the use of paracetamol and phenobarbital.
In applying cholestyramine a period of less than 1 h after administration of paracetamol 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 and its increased concentration in blood plasma.
When applied simultaneously with probenecid may decrease clearance of paracetamol, with rifampicin, sulfinpyrazone - may increase clearance of paracetamol due to increasing its metabolism in the liver.
At simultaneous application of Paracetamol with ethinylestradiol increases absorption of paracetamol 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).
Paracetamol side effects
See also:
What are the possible side effects of Paracetamol?
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, 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.
At the doses and duration of recommended treatment, side effects are usually negligible, but the prolonged use of paracetamol in therapeutic doses large (2-4 g per day, or 10-20 tablets Paracetamol) 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) is described in paragraph overdose.
Paracetamol contraindications
See also:
What is the most important information I should know about Paracetamol?
Paracetamol should not be used in patients who have previously exhibited hypersensitivity to aspirin and/or nonsteroidal antiinflammatory agents. Paracetamol should not be given to patients with a recent history of gastrointestinal bleeding or in patients with bleeding disorders (e.g., hemophilia).
Pheniramine maleate indications
this medicine contain Pheniramine maleate maleate, a medicine used to treat allergic conditions such as hayfever, runny nose, itching skin and skin rashes. It is also used in the prevention and treatment of inner ear disorders (eg Meniere’s
disease) and travel sickness.
this medicine is one of a group of medicines called’antihistamines’ which works by blocking the Pheniramine maleate of histamine.
Uses of Pheniramine maleate in details
Pheniramine maleate is used for treatment of symptoms of allergic rhinitis (e.g. sneezing, runny and itchy nose and eye irritation) and other symptoms of allergy and hay fever.
Pheniramine maleate description
One of the histamine H1 antagonists with little sedative Pheniramine maleate. It is used in treatment of hay fever, rhinitis, allergic dermatoses, and pruritus. [PubChem]
Pheniramine maleate dosage
Oral
Allergic conditions
Adult: As maleate: Syrup: 15-30 mg bid or tid. Tablet: Up to 45 mg tid. Max: 3 mg/kg/day.
Child: As maleate: 5-10 yr: Half a 45-mg tablet up to tid; >10 yr: Syrup: 15-30 mg bid or tid. Tablet: Up to 45 mg tid. Max: 3 mg/kg/day.
Elderly: As maleate: Syrup: 15-30 mg bid or tid. Tablet: Up to 45 mg tid. Max: 3 mg/kg/day.
Oral
Prophylaxis of motion sickness
Adult: As maleate: Syrup: 15-30 mg bid or tid. Tablet: Up to 45 mg tid. Max: 3 mg/kg/day. Take 1st dose at least 30 min before travelling.
Child: As maleate: 5-10 yr: Half a 45-mg tablet up to tid; >10 yr: Syrup: 15-30 mg bid or tid. Tablet: Up to 45 mg tid. Max: 3 mg/kg/day. Take 1st dose at least 30 min before travelling.
Ophthalmic
Allergic conjunctivitis
Adult: Pheniramine maleate maleate 0.3% in combination with naphazoline hydrochloride 0.025%: 1 or 2 drops in the affected eye/s up to 4 times a day.
Child: ≥6 yr: Pheniramine maleate maleate 0.3% in combination with naphazoline hydrochloride 0.025%: 1 or 2 drops in the affected eye/s up to 4 times a day.
Pheniramine maleate interactions
Some medicines and this medicine may interfere with each other. These include:
• antidepressants known as MAO inhibitors
• atropine and other anticholinergic drugs
• alcohol
• sedative drugs
Pheniramine maleate side effects
All medicines can have some unwanted side effects. Sometimes they are serious, most of the time they are not. Your doctor or pharmacist has weighed the risks of using this medicine against
the benefits they expect it will have for you. Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking this medicine.
Tell your pharmacist or doctor if you notice
any of the following and they worry you:
• drowsiness
• nervousness, irritability, incoordination, lack of concentration
• dizziness
• tinnitus (ringing in the ears)
• nausea and vomiting
• difficulty passing urine
Tell your doctor immediately if you notice any of the following:
• changes in your usual behaviour or mood
• severe sedation, confusion or restlessness
• hallucinations
• vision problems
• irregular heart beat
Pheniramine maleate contraindications
Do not take this medicine if you:
• are taking an antidepressant medicine known as a MAO Inhibitor
• are male and you have an enlarged prostate
Do not take this medicine if you are allergic to it or any of the ingredients listed at the end of this leaflet.
Some symptoms of an allergic reaction include skin rash, itching, asthma, wheezing, shortness of breath or swelling of the fact, lips or tongue,
which may cause difficulty in swallowing or breathing, fainting.
Do not take it after the expiry date (EXP) printed on the pack.
If you take it after the expiry date has passed, it may not work as well.
Do not take it if the packaging is torn or shows signs of tampering.
Do not give this medicine to a premature or newborn baby.
What is Phenylephrine hydrochloride?
Phenylephrine hydrochloride (Phenylephrine hydrochloride) is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
Phenylephrine hydrochloride is used to treat nasal and sinus congestion, or congestion of the tubes that drain fluid from your inner ears, called the eustachian (yoo-STAY-shun) tubes.
Phenylephrine hydrochloride may also be used for purposes not listed in this medication guide.
Phenylephrine hydrochloride indications
Phenylephrine hydrochloride Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.
How should I use Phenylephrine hydrochloride?
Use Phenylephrine hydrochloride as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Phenylephrine hydrochloride is for use in the eye only. Avoid contact with the nose or mouth.
- To use Phenylephrine hydrochloride, 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 hydrochloride. Sterilize contact lenses according to the manufacturer's directions and check with your doctor before using them.
- Do not use Phenylephrine hydrochloride if it is brown or contains particles.
- If you miss a dose of Phenylephrine hydrochloride, 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 hydrochloride.
Uses of Phenylephrine hydrochloride in details
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 hydrochloride, 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 hydrochloride 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 hydrochloride 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 hydrochloride is recommended for ischemic priapism that persists following aspiration/irrigation.
Phenylephrine hydrochloride description
Phenylephrine hydrochloride 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.
Phenylephrine hydrochloride dosage
General Dosing Recommendations
In patients 1 year of age or greater, apply one drop of either Phenylephrine hydrochloride hydrochloride ophthalmic solution 2.5% or 10% every 3 to 5 minutes to the conjunctival fornix as required up to a maximum of 3 drops per eye per day.
In order to obtain a greater degree of mydriasis, Phenylephrine hydrochloride hydrochloride ophthalmic solution 10% may be needed.
Dosing in Pediatric Patients Less Than 1 Year of Age
In pediatric patients less than 1 year of age, one drop of Phenylephrine hydrochloride hydrochloride ophthalmic solution 2.5% should be instilled at 3 to 5 minute intervals up to a maximum of 3 drops per eye.
Phenylephrine hydrochloride interactions
See also:
What other drugs will affect Phenylephrine hydrochloride?
Atropine
Concurrent use may enhance the pressor effects and induce tachycardia, especially in infants.
Beta-blockers
Decrease Phenylephrine hydrochloride’s effect.
Digitalis glycosides, general anesthetics
Arrhythmias.
Furazolidone, MAOIs
May significantly increase pressor response resulting in hypertensive crisis and intracranial hemorrhage.
Guanethidine, methyldopa, reserpine
May increase pressor response of Phenylephrine hydrochloride; resulting in severe hypertension.
Halogenated hydrocarbon anesthetics
May sensitize myocardium to effects of catecholamines. Use extreme caution to avoid arrhythmias.
Oxytocic drugs
May cause severe persistent hypertension.
Tricyclic antidepressants
May decrease or increase response; use with caution.
Laboratory Test Interactions
Products with potassium guaiacolsulfonate may increase renal Cl for urate and thereby lower serum uric acid levels; may increase urinary 50 hydroxyindoleacetic acid; may falsely elevate VMA test for catecholis.
Phenylephrine hydrochloride side effects
See also:
What are the possible side effects of Phenylephrine hydrochloride?
The following serious adverse reactions are described below and elsewhere in the labeling:
- Cardiovascular Effects
- Elevation in Blood Pressure
The following adverse reactions have been identified following use of Phenylephrine hydrochloride hydrochloride ophthalmic solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Ocular Adverse Reactions
Eye pain and stinging on instillation, temporary blurred vision and photophobia, and conjunctival sensitization may occur.
Systemic Adverse Reactions
A marked increase in blood pressure has been reported particularly, but not limited to low weight premature neonates, infants and hypertensive patients.
Cardiovascular effects which have been seen primarily in hypertensive patients following topical ocular use of Phenylephrine hydrochloride hydrochloride ophthalmic solution 10% include marked increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia and subarachnoid hemorrhage.
Phenylephrine hydrochloride contraindications
See also:
What is the most important information I should know about Phenylephrine hydrochloride?
Cardiac and Endocrine Disease
Phenylephrine hydrochloride hydrochloride ophthalmic solution 10% is contraindicated in patients with hypertension or thyrotoxicosis. Phenylephrine hydrochloride hydrochloride ophthalmic solution 2.5% should be used in these patients.
Pediatric Patients Less Than 1 Year of Age
Phenylephrine hydrochloride hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age due to the increased risk of systemic toxicity. Phenylephrine hydrochloride hydrochloride ophthalmic solution 2.5% should be used in these patients.
Active ingredient matches for Ascorbic acid/paracetamol/pheniramine maleate/Phenylephrine hydrochloride:
Ascorbic acid/paracetamol/pheniramine maleate/Phenylephrine hydrochloride
References
- PubChem. "phenylephrine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- PubChem. "pheniramine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "pheniramine". http://www.drugbank.ca/drugs/DB01620 (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
