Liometacen Side effects

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Side effects of Liometacen in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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The following adverse reactions are discussed in greater detail in other sections of the labeling:

•Cardiovascular Thrombotic Events

•GI Bleeding, Ulceration and Perforation

•Hepatotoxicity

•Hypertension

•Heart Failure and Edema

•Renal Toxicity and Hyperkalemia

•Anaphylactic Reactions

•Serious Skin Reactions

•Hematologic Toxicity

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In a gastroscopic study in 45 healthy subjects, the number of gastric mucosal abnormalities was significantly higher in the group receiving Liometacen immediate-release capsules than in the group taking Liometacen suppositories or placebo.

In a double-blind comparative clinical study involving 175 patients with rheumatoid arthritis, however, the incidence of upper gastrointestinal adverse effects with Liometacen immediate-release capsules or suppositories was comparable. The incidence of lower gastrointestinal adverse effects was greater in the suppository group.

The adverse reactions for Liometacen immediate-release capsules listed in the following table have been arranged into two groups: (1) incidence greater than 1%; and (2) incidence less than 1%. The incidence for group (1) was obtained from 33 double-blind controlled clinical trials reported in the literature (1,092 patients). The incidence for group (2) was based on reports in clinical trials, in the literature, and on voluntary reports since marketing. The probability of a causal relationship exists between Liometacen capsules and these adverse reactions, some of which have been reported only rarely.

The adverse reactions reported with Liometacen immediate-release capsules may occur with use of the suppositories. In addition, rectal irritation and tenesmus have been reported in patients who have received the capsules.

Table 1 Summary of Adverse Reactions for Liometacen Capsules

Inci d ence greater than 1%

In cidence l e ss than 1%

GAST ROINTE STINAL

na u sea* wi th orwi thout v o mi ti ng

d y sp ep s ia* ( inc lud ing

ind igest io n, hear tb urn a nd e p ig astr ic p a in)

di arr h ea

ab d o minal dis tr ess or pa in co n s tip ati on

a norexia

b loat ing ( inc ludes d is te ns ion)

flatul e nce

pep tic ulcer

gas tro e n ter it is

rectal b leeding

p roc ti tis

s in g le or m u lti ple ulc erat io ns,

i nc lu d i ng p e rforat i on and h em or r h ageof t he es o ph ag us, s tomach,d u od en um or smallandlargeintestines

intestinalulcerationassociatedwith

stenosisandobstruction

gastrointestinalbleedingwithout

obviousulcerformationandperforationofpreexistingsigmoidlesions(diverticulum,carcinoma,etc.)developmentofulcerativecolitisandregionalileitis

ulcerativestomatitis

toxichepatitisandjaundice

(somefatalcaseshavebeenreported)

intestinalstrictures

(diaphragms)

CENTRALNERVOUSSYSTEM

headache(11.7%)dizziness*

vertigo

somnolence

depressionandfatigue

(includingmalaiseandlistlessness)

anxiety(includesnervousness)

muscleweakness

involuntarymusclemovements

insomnia

muzziness

psychicdisturbancesincluding

psychoticepisodes

mentalconfusion

drowsiness

light-headedness

syncope

paresthesia

aggravationofepilepsyand

parkinsonism

depersonalization

coma

peripheralneuropathy

convulsion

dysarthria

SPECIALSENSES

tinnitus

ocular—cornealdepositsandretinal

disturbances,includingthoseofthemacula,havebeenreportedin somepatientsonprolongedtherapy with

Liometacen capsules

blurredvision

diplopia

hearingdisturbances,deafness

CARDIOVASCULAR

None

hypertension

hypotension

tachycardia

chest pain

congestiveheartfailurearrhythmia;palpitations

METABOLIC

None

edema

weight gain

fluid retention

flushing or sweating

hyperglycemia

glycosuria

hyperkalemia

INTEGUMENTARY

none

pruritus

rash;urticaria

petechiaeorecchymosis

exfoliativedermatitis

erythemanodosum

lossofhair

Stevens-Johnsonsyndromeerythemamultiforme

toxicepidermalnecrolysis

HEMATOLOGIC

None

leukopenia

bonemarrowdepression

anemiasecondarytoobviousoroccult

gastrointestinalbleeding

aplasticanemia

hemolyticanemia

agranulocytosis

thrombocytopenicpurpuradisseminatedintravascular

coagulation

HYPERSENSITIVITY

None

acute anaphylaxis

acute respiratory distress

rapid fall in blood pressure resembling

a shock-like state

angioedema

dyspnea

asthma

purpura

angiitis

pulmonary edema

fever

GENITOURINARY

None

Hematuria

vaginalbleeding

proteinuria

nephroticsyndrome

interstitialnephritis

BUNelevation

renalinsufficiency,includingrenalfailure

MISCELLANEOUS

None

epistaxis

breastchanges,includingenlargement

andtenderness,orgynecomastia

*Reactionsoccurringin3%to9%ofpatients treatedwithindomethacin capsules.(Thosereactionsoccurringinless than3%ofthepatientsareunmarked.)

Causal relationship unknown: Other reactions have been reported but occurred under circumstances where a causal relationship could not be established. However, in these rarely reported events, the possibility cannot be excluded. Therefore, these observations are being listed to serve as alerting information to physicians:

Cardiovascular: Thrombophlebitis

Hematologic: Although there have been several reports of leukemia, the supporting information is weak

Genitourinary: Urinary frequency

A rare occurrence of fulminant necrotizing fasciitis, particularly in association with Group Aβ hemolytic streptococcus, has been described in persons treated with nonsteroidal anti-inflammatory agents, including Liometacen, sometimes with fatal outcome.

Liometacen contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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Known hypersensitivity to Liometacen, aspirin or other NSAIDs. Neonates w/ congenital heart disease when patency of the ductus arteriosus is needed for adequate pulmonary or systemic blood flow (e.g. neonates w/ pulmonary atresia, severe tetralogy of Fallot or severe coarctation of the aorta). Neonates w/ proven or suspected untreated infection, necrotising enterocolitis, impaired renal function, active bleeding (e.g. intraventricular haemorrhage or GI bleeding), thrombocytopenia or underlying coagulation defect. Patient w/ history of proctitis or recent rectal bleeding. History of asthma, urticaria, allergic-type reactions. Treatment of perioperative pain in the setting of CABG surgery. Concurrent use w/ diflunisal.

References

  1. DailyMed. "INDOMETHACIN: 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).
  2. DTP/NCI. "indomethacin: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
  3. European Chemicals Agency - ECHA. "Indometacin: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Liometacen are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Liometacen. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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