Consists of chlorpheniramine, paracetamol, phenylephrine
Actions of Chlorpheniramine (Cold OFF) in details
Chlorpheniramine (Cold OFF) belongs to class of medications called antihistamines. It acts by blocking a natural chemical (histamine) that your body makes during an allergic reaction. Histamine is responsible for many symptoms of allergy.
How should I take Chlorpheniramine (Cold OFF)?
This section provides information on the proper use of a number of products that contain cough and cold combinations. It may not be specific to Chlorpheniramine (Cold OFF). Please read with care.
To help loosen mucus or phlegm in the lungs, drink a glass of water after each dose of this medicine, unless otherwise directed by your doctor.
Take this medicine only as directed. Do not take more of it and do not take it more often than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of side effects.
Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects.
For patients taking the extended-release capsule or tablet form of this medicine:
- Swallow the capsule or tablet whole.
- Do not crush, break, or chew before swallowing.
- If the capsule is too large to swallow, you may mix the contents of the capsule with applesauce, jelly, honey, or syrup and swallow without chewing.
For patients taking the extended-release oral solution or oral suspension form of this medicine:
- Do not dilute with fluids or mix with other drugs.
For patients taking a combination medicine containing an antihistamine and/or aspirin or other salicylate:
- Take with food or a glass of water or milk to lessen stomach irritation, if necessary.
If a combination medicine containing aspirin has a strong vinegar-like odor, do not use it. This odor means the medicine is breaking down. If you have any questions about this, check with your pharmacist.
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Keep out of the reach of children.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Do not keep outdated medicine or medicine no longer needed.
Keep the liquid form of this medicine from freezing. Do not refrigerate the syrup.
Chlorpheniramine (Cold OFF) administration
Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This medicine is usually taken only for a short time until your symptoms clear up.
Do not take for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.
Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time.
Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.
If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days.
Store at room temperature away from moisture and heat. Do not allow the liquid form of this medicine to freeze.
Chlorpheniramine (Cold OFF) pharmacology
Chlorpheniramine (Cold OFF) acts directly on both alpha- and, to a lesser degree, beta-adrenergic receptors. Through direct action on alpha-adrenergic receptors in the mucosa of the respiratory tract, pseudoephedrine produces vasoconstriction. Chlorpheniramine (Cold OFF) relaxes bronchial smooth muscle by stimulating beta2-adrenergic receptors. Like ephedrine, pseudoephedrine releasing norepinephrine from its storage sites, an indirect effect.
Actions of Paracetamol (Cold OFF) in details
Pharmacology: Paracetamol (Cold OFF) exhibits analgesic and antipyretic activity by inhibiting prostaglandin synthesis. It produces analgesia by elevating the pain threshold and antipyresis through action on the hypothalamic heat-regulating center.
In therapeutic doses, Paracetamol (Cold OFF)'s analgesic and antipyretic action is comparable to that of aspirin. Paracetamol (Cold OFF) does not adversely affect platelet function and hemostasis.
Pharmacokinetics: Paracetamol (Cold OFF) is rapidly and completely absorbed after oral administration. Peak plasma concentrations occur between 15 min to 2 hrs after ingestion. The absolute oral bioavailability of Paracetamol (Cold OFF) is about 80% and is independent of dose in the range of 5-20 mg/kg.
Paracetamol (Cold OFF) is not bound to plasma proteins to any extent. The concentrations of Paracetamol (Cold OFF) in saliva are similar to those in plasma. Concentrations in whole blood are up to 20% higher and in breast milk about 20% lower than the plasma concentration. Paracetamol (Cold OFF) crosses the placenta.
Paracetamol (Cold OFF) is extensively metabolized in the liver and the total body clearance is about 5 mL/kg/min. The clearance of Paracetamol (Cold OFF) is reduced and the half-life increased following a hepatotoxic overdose. Prolongation of half-life beyond 4 hrs usually indicates impending liver damage.
Two to five percent of a therapeutic dose of Paracetamol (Cold OFF) is excreted unchanged in the urine. Its renal clearance is about 10 mL/min and is weakly dependent on urine flow rate but not on pH.
Paracetamol (Cold OFF) administration
May be taken with or without food.
Paracetamol (Cold OFF) pharmacology
The analgesic, antipyretic, and anti-inflammatory effects of aspirin are due to actions by both the acetyl and the salicylate portions of the intact molecule as well as by the active salicylate metabolite. Paracetamol (Cold OFF) directly and irreversibly inhibits the activity of both types of cyclo-oxygenase (COX-1 and COX-2) to decrease the formation of precursors of prostaglandins and thromboxanes from arachidonic acid. This makes aspirin different from other NSAIDS (such as diclofenac and ibuprofen) which are reversible inhibitors. Salicylate may competitively inhibit prostaglandin formation. Paracetamol (Cold OFF)'s antirheumatic (nonsteroidal anti-inflammatory) actions are a result of its analgesic and anti-inflammatory mechanisms; the therapeutic effects are not due to pituitary-adrenal stimulation. The platelet aggregation–inhibiting effect of aspirin specifically involves the compound's ability to act as an acetyl donor to the platelet membrane; the nonacetylated salicylates have no clinically significant effect on platelet aggregation. Paracetamol (Cold OFF) affects platelet function by inhibiting the enzyme prostaglandin cyclooxygenase in platelets, thereby preventing the formation of the aggregating agent thromboxane A2. This action is irreversible; the effects persist for the life of the platelets exposed. Paracetamol (Cold OFF) may also inhibit formation of the platelet aggregation inhibitor prostacyclin (prostaglandin I2) in blood vessels; however, this action is reversible.
Actions of Phenylephrine (Cold OFF) in details
In general, α1-adrenergic receptors mediate contraction and hypertrophic growth of smooth muscle cells. α1-receptors are 7-transmembrane domain receptors coupled to G proteins, Gq/11. Three α1-receptor subtypes, which share approximately 75% homology in their transmembrane domains, have been identified: α1A (chromosome 8), α1B (chromosome 5), and α1D (chromosome 20). Phenylephrine (Cold OFF) appears to act similarly on all three receptor subtypes. All three receptor subtypes appear to be involved in maintaining vascular tone. The α1A-receptor maintains basal vascular tone while the α1B-receptor mediates the vasocontrictory effects of exogenous α1-agonists. Activation of the α1-receptor activates Gq-proteins, which results in intracellular stimulation of phospholipases C, A2, and D. This results in mobilization of Ca2+ from intracellular stores, activation of mitogen-activated kinase and PI3 kinase pathways and subsequent vasoconstriction. Phenylephrine (Cold OFF) produces its local and systemic actions by acting on α1-adrenergic receptors peripheral vascular smooth muscle. Stimulation of the α1-adrenergic receptors results in contraction arteriolar smooth muscle in the periphery. Phenylephrine (Cold OFF) decreases nasal congestion by acting on α1-adrenergic receptors in the arterioles of the nasal mucosa to produce constriction; this leads to decreased edema and increased drainage of the sinus cavities.
How should I take Phenylephrine (Cold OFF)?
Do not use if the solution turns brown or becomes cloudy.
To use:
- First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 2 or 3 minutes to allow the medicine to be absorbed by the eye.
- Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.
- To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.
For patients using the 2.5 or 10% eye drops:
- It is very important that you use Phenylephrine (Cold OFF) only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects. This is especially important when Phenylephrine (Cold OFF) is used in children or in patients with heart disease or high blood pressure, since high doses of Phenylephrine (Cold OFF) may cause an irregular heartbeat and an increase in blood pressure.
Dosing
The dose of Phenylephrine (Cold OFF) will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of Phenylephrine (Cold OFF). If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For ophthalmic solution (eye drops) dosage form:
- For eye redness:
- Adults and children—Use one drop of 0.12% solution every three or four hours as needed.
- For eye exams:
- Adults and children—Use one drop of 2.5% solution. Depending on the eye test to be done, it will take from fifteen minutes to one or two hours for the medicine to work before you can have the eye test.
- For use before eye surgery:
- Adults and teenagers—Use one drop of 2.5 or 10% solution thirty to sixty minutes before the start of eye surgery.
- Children—Use one drop of 2.5% solution thirty to sixty minutes before the start of eye surgery.
- For certain eye conditions:
- Adults and teenagers—Depending on the eye condition being treated, your doctor may tell you to use one drop of 2.5 or 10% solution in the eye from once a day to three times a day.
- Children—Depending on the eye condition being treated, your doctor may tell you to use one drop of 2.5% solution in the eye from once a day to three times a day.
- For eye redness:
Missed Dose
If you miss a dose of Phenylephrine (Cold OFF), take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
For non-prescription strength eye drops, follow the package directions.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Phenylephrine (Cold OFF) administration
IV:
Hypotension/shock: May be administered via continuous infusion (after diluting). When administering as a continuous infusion, central line administration is preferred. IV infusions require an infusion pump.
Hypotension during anesthesia: Administer as an IV bolus over 20 to 30 seconds.
Vesicant; ensure proper needle or catheter placement prior to and during infusion; avoid extravasation.
Extravasation management: If extravasation occurs, stop infusion immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); remove needle/cannula; elevate extremity. Initiate phentolamine (or alternative antidote). Apply dry warm compresses (Hurst 2004; Reynolds 2014).
Phentolamine: Dilute 5 to 10 mg in 10 to 20 mL NS and administer into extravasation site as soon as possible after extravasation; may readminister if patient remains symptomatic (Reynolds 2014).
Alternative to phentolamine: Nitroglycerin topical 2% ointment (based on limited data): Apply a 1-inch strip to the site of ischemia; may repeat every 8 hours as necessary (Reynolds 2014).
Phenylephrine (Cold OFF) pharmacology
Mechanism Of Action
Phenylephrine (Cold OFF) hydrochloride is an a-1 adrenergic receptor agonist.
Pharmacodynamics
Interaction of Phenylephrine (Cold OFF) with a1-adrenergic receptors on vascular smooth muscle cells causes activation of the cells and results in vasoconstriction. Following Phenylephrine (Cold OFF) hydrochloride intravenous administration, increases in systolic and diastolic blood pressures, mean arterial blood pressure, and total peripheral vascular resistance are observed. The onset of blood pressure increase following an intravenous bolus Phenylephrine (Cold OFF) hydrochloride administration is rapid, typically within minutes. As blood pressure increases following intravenous administration, vagal activity also increases, resulting in reflex bradycardia.
Phenylephrine (Cold OFF) has activity on most vascular beds, including renal, pulmonary, and splanchnic arteries.
Pharmacokinetics
Following an intravenous infusion of Phenylephrine (Cold OFF) hydrochloride, the observed effective halflife was approximately 5 minutes. The steady-state volume of distribution of approximately 340 L suggests a high distribution into organs and peripheral tissues. The average total serum clearance is approximately 2100 mL/min. The observed Phenylephrine (Cold OFF) plasma terminal elimination half-life was 2.5 hours.
Phenylephrine (Cold OFF) is metabolized primarily by monoamine oxidase and sulfotransferase. After intravenous administration of radiolabeled Phenylephrine (Cold OFF), approximately 80% of the total dose was eliminated within first 12 h; and approximately 86% of the total dose was recovered in the urine within 48 h. The excreted unchanged parent drug was 16% of the total dose in the urine at 48 h post intravenous administration. There are two major metabolites, with approximately 57 and 8% of the total dose excreted as m-hydroxymandelic acid and sulfate conjugates, respectively. The metabolites are considered not pharmacologically active.
Clinical Studies
The evidence for the efficacy of Phenylephrine (Cold OFF) is derived from studies of Phenylephrine (Cold OFF) hydrochloride in the published literature. The literature support includes 16 studies evaluating the use of intravenous Phenylephrine (Cold OFF) to treat hypotension during anesthesia. The 16 studies include 9 studies where Phenylephrine (Cold OFF) was used in low-risk (ASA 1 and 2) pregnant women undergoing neuraxial anesthesia during Cesarean delivery, 6 studies in non-obstetric surgery under general anesthesia, and 1 study in non-obstetric surgery under combined general and neuraxial anesthesia. Phenylephrine (Cold OFF) has been shown to raise systolic and mean blood pressure when administered either as a bolus dose or by continuous infusion following the development of hypotension during anesthesia.
References
- DailyMed. "CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- NCIt. "Phenylephrine: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
- NCIt. "Chlorpheniramine Maleate: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
