Combofresh Ophthalmic Solution 0.2%+0.36%+1%+0.05%+0.25%

Uses

Combofresh Ophthalmic Solution 0.2%+0.36%+1%+0.05%+0.25% is also used to associated treatment for these conditions: Cold Sore, Constipation, Dry Mouth, Dry Skin, Dry throat, Edema of the cerebrum, Hypertension Intracranial, Occasional Constipation, Ocular Discomfort, Ocular Hypertension, Ocular Irritation, Skin Infections, Sore Throat, Mouth soreness, Ocular burning, Bowel preparation therapy, Topical Antisepsis, Skin protectionDry Eyes, Ocular Discomfort, Ocular IrritationChronic Constipation, Constipation, Dry Eye Syndrome (DES), Dry Eyes, Occasional Constipation, Bowel preparation therapy, Eye lubricationDry Eyes, Local itching, Localized pain, Localized swelling, Nutritional supplementation

How Combofresh Ophthalmic Solution 0.2%+0.36%+1%+0.05%+0.25% works

When administered rectally, glycerin exerts a hygroscopic and/or local irritant action, drawing water from the tissues into the feces and reflexively stimulating evacuation. Glycerin decreases intraocular pressure by creating an osmotic gradient between the blood and intraocular fluid, causing fluid to move out of the aqueous and vitreous humors into the bloodstream.

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 .

Osmotic laxatives contain substances that are poorly absorbable and draw water into the lumen of the bowel. Polyethylene glycol functions is an osmotic laxative that causes increased water retention in the lumen of the colon by binding to water molecules, thereby producing loose stools.

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

Combofresh Ophthalmic Solution 0.2%+0.36%+1%+0.05%+0.25% dosage

It should always be taken by mouth. Measure the dose using the supplied cup, stir and dissolve in a glass of water, juice, coke, coffee or tea. Taking more than the prescribed dose may cause loss of fluid due to severe diarrhea.

Duration of Treatment

Polyethylene Glycol achieves its best results when used between one and two weeks. It may be discontinued after several satisfactory bowel movements. Should unusual cramps, bloating, or diarrhea occur, consultation with physician is needed. Polyethylene Glycol is intended for up to a two-week course of therapy. It should not be used for a longer time unless directed by a physician. After successfully completing the Polyethylene Glycol therapy (usually between one and two weeks) discussion with a physician is needed to change lifestyle that may produce more regular bowel habits (adequate dietary and fluid intake, regular exercise).

Side Effects

Toxicity

Glycerol has very low toxicity when ingested ; Rat LD50 (oral)-12600mg/kg Mice LD50 (oral )-4090mg/kg Human TDLo (oral) - 1428mg/kg

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 .

The oral LD₅₀ of PEG 3350 in rats is 22000 mg/kg.

There is limited clinical information on the overdose of polyethylene glycols. Based on the pharmacological action of the compound, severe diarrhea may be suspected. Overdose of polyethylene glycols should be responded with symptomatic and supportive care.

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

Interaction

Volume of Distribution

Glycerin is distributed throughout the blood. Although glycerin generally does not appear in ocular fluids, it may enter the orbital sac when the eye is inflamed, with a consequent decrease in osmotic effect.

Following a two-day split-dosing regimen of an oral suspension containing 140 grams of PEG 3350 in healthy subjects, the mean volume of distribution was 48,481 L.

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 orally, poorly absorbed rectally. Studies in humans and animals indicate glycerol is rapidly absorbed in the intestine and the stomach

Not systemically absorbed .

Following a two-day split-dosing regimen of an oral suspension containing 140 grams of PEG 3350 in healthy subjects, the mean Cmax was 2.7 mcg/mL and the mean Tmax was 3 hours. Typically, polyethylene glycols with a high molecular weight are poorly absorbed from the gastrointestinal tract following oral administration.

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

30 - 45 minutes

Following a two-day split-dosing regimen of an oral suspension containing 140 grams of PEG 3350 in healthy subjects, the mean half life was 4.1 hours.

3 hours

Clearance

There is limited information on the clearance rate of polyethylene glycols.

Elimination Route

Approx 7-14% of dose is excreted unchanged in the urine within 2.5 hr.

Following administration of an oral suspension containing 140 grams of PEG 3350 in healthy subjects, up to 85% to 99% of the compound was excreted in the feces.

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

Pregnancy & Breastfeeding use

Contraindication

Acute Overdose

No case of overdose has been reported.

There have been no reports of accidental overdosage. In the event of overdosage diarrhea would be the expected major event. If an overdose of drug occurred without concomitant ingestion of fluid, dehydration due to diarrhea may result. Medication should be terminated and free water administered.

Storage Condition

Innovators Monograph

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