I Kul Plus

Uses

Indicated mainly in allergic conditions including urticaria, sensitivity reactions, angioneurotic oedema, seasonal hay fever, vasomotor rhinitis, cough, common cold, motion sickness.

Hypromellose enriched with Carbomer 980 is a long acting eye gel for lubricating the surface of the eye for all patients with ocular discomfort. The slight hypotonicity of the gel is rapidly "neutralised" by the slightly hypertonic tear fluid caused by dry eyes.

Naphazoline is a sympathomimetic vasoconstrictor used for the symptomatic relief of redness and itching of the eye, and nasal congestion.

Naphazoline is indicated for use as OTC eyedrops for ocular vasoconstriction or as a nasal preparation for nasal congestion.

Zinc sulfate is a drug used to replenish low levels of zinc or prevent zinc deficiency, or to test for zinc deficiency.

This medication is a mineral used to treat or prevent low levels of zinc alone and together with oral rehydration therapy (ORT). It is also used as a topical astringent. Zinc Sulfate Injection, USP is indicated for use as a supplement to intravenous solutions given for TPN.

I Kul Plus is also used to associated treatment for these conditions: Allergic Contact Dermatitis, Allergic Reaction, Allergic Rhinitis (AR), Allergic cough, Allergies, Allergies caused by Serum, Allergy to House Dust, Allergy to vaccine, Angioneurotic Edema, Asthma, Bronchial Asthma, Bronchitis, Common Cold, Conjunctival congestion, Conjunctivitis, Conjunctivitis allergic, Cough, Cough caused by Common Cold, Coughing caused by Flu caused by Influenza, Drug Allergy, Eye allergy, Fever, Flu caused by Influenza, Food Allergy, Headache, Headache caused by Allergies, Itching of the nose, Itching of the throat, Migraine, Nasal Congestion, Nasal Congestion caused by Common Cold, Pollen Allergy, Productive cough, Pruritus, Rash, Rhinorrhoea, Seasonal Allergic Conjunctivitis, Sinus Congestion, Sinusitis, Sneezing, Transfusion Reactions, Upper Respiratory Tract Infection, Upper respiratory tract hypersensitivity reaction, site unspecified, Urticaria, Vasomotor Rhinitis, Acute Rhinitis, Allergic purpura, Conjunctival hyperemia, Dry cough, Excess mucus or phlegm, Itchy throat, Mild bacterial upper respiratory tract infections, Ocular hyperemia, Throat inflammation, Upper airway congestion, Upper respiratory symptoms, Watery eyes, Watery itchy eyes, Airway secretion clearance therapyDry Eyes, Ocular Discomfort, Ocular IrritationBacterial Conjunctivitis, Blepharoconjunctivitis, Conjunctivitis, Conjunctivitis allergic, Dacryocystitis, Dacryostenosis, Dermatitis, Eczematous of the Eyelid, Eye Pain, Eye redness, Iritis, Lacrimation, Nasal Allergies, Nasal Congestion, Noninfective conjunctivitis, Otitis Media (OM), Photophobia, Foreign body sensation in eye, Ocular bacterial infections, Ocular vasoconstrictionDry Eyes, Local itching, Localized pain, Localized swelling, Nutritional supplementation

How I Kul Plus works

Chlorpheniramine binds to the histamine H1 receptor. This blocks the action of endogenous histamine, which subsequently leads to temporary relief of the negative symptoms brought on by histamine.

Promotes corneal wetting by the stabilization and thickening the precorneal tear film and prolonging the tear film breakdown time, which is usually shortened in dry eye conditions. Hypromellose also acts to lubricate and protect the eye .

The surface active properties of the vehicles found in artificial tears solutions act to stabilize the tear film and increase tear viscosity to prevent delay tear evaporation and delay tear drainage .

In the intact eye, the corneal surface is moistened primarily by the mucin that is produced in the conjunctiva. Mucin is adsorbed on the corneal surface and forms a hydrophilic surface. This creates a moisture barrier. In the typical dry eye, and particularly in case of mucin deficiency, the application of artificial tear fluid is highly recommended. Both its surface activity and its adsorptive capacity make hypromellose optimal for this use. Hypromellose has a physical-chemical action and leads to, in an aqueous solution, a reduced surface tension as well as an increased level of viscosity. Hypromellose adheres well to the cornea and conjunctiva and provides ample moisture. Irritation symptoms caused by blinking, which occur in the case of tear fluid deficiency, are therefore decreased and symptoms of epithelial desiccation are also alleviated .

Naphazoline is a vasoconstrictor that functions by stimulating alpha adrenergic receptors in arterioles leading to decreased congestion at the site of administration.

Naphazoline causes the release of norepinephrine in sympathetic nerves. Norepinephrine binds to alpha adrenergic receptors and causes vasoconstriction. Naphazoline is also a mild beta adrenergic receptor agonist, which can cause rebound vasodilation after the alpha adrenergic stimulation has ended. Naphazoline's release of norepinephrine also triggers a negative feedback loop which decreases production of norepinephrine, which can lead to rhinitis medicamentosa after long term use when naphazoline is stopped.

Zinc inhibits cAMP-induced, chloride-dependent fluid secretion by inhibiting basolateral potassium (K) channels, in in-vitro studies with rat ileum. This study has also shown the specificity of Zn to cAMP-activated K channels, because zinc did not block the calcium (Ca)-mediated K channels. As this study was not performed in Zn-deficient animals, it provides evidence that Zn is probably effective in the absence of Zn deficiency. Zinc also improves the absorption of water and electrolytes, improves regeneration of the intestinal epithelium, increases the levels of brush border enzymes, and enhances the immune response, allowing for a better clearance of the pathogens.

Dosage

I Kul Plus dosage

Adults: 4 mg 3-4 times daily.

Children:

• Up to 1( one) year: 1 mg twice daily
• 1-5 years: 1 mg 3-4 times daily
• 6-12 years: 2 mg 3-4 times daily or as directed by the physician

Instill 1 or 2 drops in the conjunctival sac of the affected eye(s), as needed. The frequency of administration depends on the severity of the condition. On average, one drop is administered 1-3 times daily. If needed, Hypromellose may be administered more frequently.

Side Effects

Drowsiness, dizziness, headache, psychomotor impairment, urinary retention, dry mouth, blurred vision and gastro intestinal disturbances, paradoxical stimulation may rarely occur, especially in high dosage or in children.

Hypromellose enriched with Carbomer 980 is very well tolerated by users. However, some cases of burning, stinging, allergic reactions or red eyes after instillation have been reported. Transient blurring of vision after administration has also been reported.

Toxicity

Oral LD50 (rat): 306 mg/kg; Oral LD50 (mice): 130 mg/kg; Oral LD50 (guinea pig): 198 mg/kg [Registry of Toxic Effects of Chemical Substances. Ed. D. Sweet, US Dept. of Health & Human Services: Cincinatti, 2010.] Also a mild reproductive toxin to women of childbearing age.

LD 50 (Rat): > 5 g/kg .

Hypromellose is considered low toxicity to non-toxic .

Adverse events may include blurred vision and contact dermatitis . Hypersensitivity and intolerance reactions may occur (for example, eye burning, pain, increased lacrimation, a sensation of foreign body, conjunctival hyperemia, eyelid swelling, pruritus). The stickiness sensation of the eyelids, the decreased sense of smell, photosensitivity .

In high doses or when ingested, naphazoline can lead to central nervous system depression (which can progress to coma and death), hypothermia, bradycardia, and death. This effect is especially pronounced in children under 6 years.

Long term use of naphazoline can lead to rhinitis medicamentosa once naphazoline is stopped. This condition is a result of norepinephrine release by naphazoline triggering a negative feedback loop.

Safety and effectiveness in children under 12 has not been established. Studies in elderly patients have yet to be performed. Risk in pregnancy, breast feeding, and on overall fertility have not been established, though pregnant and breast feeding patients should consider the risk and benefit before starting naphazoline treatment.

Human : TDLo ( Oral) 45mg/kg/7D-C : Normocytic anemia, pulse rate increase without fall inBP Human: TDLo (oral) 106mg/kg : Hypermotylity, diarrhea Mouse ; LD50 Oral : 245mg/kg Mouse : LD50 : subcutaneous : 781mg/kg

Precaution

Chlorpheniramine may produce mild sedation and it is advised that patients under continuous treatment should avoid operating machinery. Not recommended during pregnancy & lactation.

If eye pains, changes in vision, continued redness or irritation of the eye are noticed Hypromellose must be discontinued and a doctor should be consulted. If Hypromellose changes color or becomes cloudy, the product should not be used.

Interaction

Alcohol, CNS depressants, anticholinergic drugs, MAOIs.

Hypromellose can be used in combination with contact lenses. No compatibility study with lens material is available.

Volume of Distribution

Distribution data for naphazoline are scarce but imidazoline compounds are distributed throughout the body, and can cross the blood-brain barrier.

After absorption zinc is bound to protein metallothionein in the intestines. Zinc is widely distributed throughout the body. It is primarily stored in RBCs, WBCs, muscles, bones, Skin, Kidneys, Liver, Pancreas, retina, and prostate.

Elimination Route

Well absorbed in the gastrointestinal tract.

Not systemically absorbed .

Absorption data for naphazoline are scarce but imidazoline compounds in general are weakly basic and lipophilic, with high bioavailability from the gastrointestinal tract.

Approximately 20 to 30% of dietary zinc is absorbed, primarily from the duodenum and ileum. The amount absorbed is dependent on the bioavailability from food. Zinc is the most bioavailable from red meat and oysters. Phytates may impair absorption by chelation and formation of insoluble complexes at an alkaline pH. After absorption, zinc is bound in the intestine to the protein metallothionein. Endogenous zinc can be reabsorbed in the ileum and colon, creating an enteropancreatic circulation of zinc.

Half Life

21-27 hours

Half life has not been determined but effects last for 4 to 8 hours. Other imidazoline compounds have half lives varying from 2 to 12 hours.

3 hours

Clearance

Clearance data for naphazoline is unavailable.

Elimination Route

Imidazoline compounds undergo some hepatic metabolism but a large fraction of the dose may be excreted unchanged in the urine. Urinary excretion is higher with more acidic urine.

Primarily fecal (approximately 90%); to a lesser extent in the urine and in perspiration.

Pregnancy & Breastfeeding use

Pregnancy Category B. Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

There is no experience regarding the safety of Hypromellose in human pregnancy or lactation. Studies in the pediatric population have not been performed.

Contraindication

There is no definite contraindication to therapy. It should be used with caution in epilepsy, prostatic hypertrophy, glaucoma and hepatic disease. The ability to drive or operate machinery may be impaired.

Hypersensitivity to this drug or to any ingredient in the formulation or component of the container.

Acute Overdose

No case of overdose has been reported.

Storage Condition

Store in a cool dry place, away from light. Keep out of reach of children. Do not touch tip of the tube surface since this may contaminate the gel. After one month of the opening do not use the medicine of tube.

Innovators Monograph

You find simplified version here I Kul Plus